http://www.newscientistjobs.com/jobsNew Scientist Jobshttp://www.newscientistjobs.com/jobs/job/senior-renewable-energy-consultant-oxfordshire-united-kingdom-200643645.htmThu, 19 Nov 2009 10:48:15 +0000192988Senior Energy Consultant-Renewable energy-Oxford We are looking for a senior individual to work within the renewables team in this leading European energy consultancy. The individual needs to have had exposure to the investment or operation of European renewable generators such as offshore/onshore and /or biomass experience. They also need to be aux fait with the UK renewables market and carbon policy sector and be experienced in at least of the 2 of the following. M&A, project development, project implementation, project financing and corporate strategy within the European energy markets. Additional languages and experience of analysis and modelling of the electricity markets is extra welcome. http://www.newscientistjobs.com/jobs/job/senior-environmental-consultant-bath-renewable-energy-bath-200643632.htmThu, 19 Nov 2009 10:38:04 +0000192982Senior Environmental Consultant - Renewable Energy-Bath Our client works successfully in the renewable energy consultancy sector within the UK and Europe. They are growing in all areas and now seek a senior environmental consultant to complement their Bath office team. With an enviable world class client base and experience since 1995 in project management, due diligence, engineering and environmental expertise and consultancy services in the renewable energy sector this is a fantastic opportunity to progress in a meritocratic fashion with the backing of a recognised name. As a Senior Environmental Consultant within the environment team, you will work closely with the Head of the Environment team delivering and growing their consultancy services to renewable energy sector clients. Assisting offshore and onshore renewable clients with their planning ( & EIA) and environmental projects will form a key part of this role. Ideally, they are looking for an experienced environmental consultant with a comprehensive knowledge and understanding of the environmental, EIA, planning and regulatory requirements within the wind energy, marine environment and renewable energy sector. Excellent project management, business development, communication and report writing skills are all expected. As you will be assisting to lead and grow this highly successfully environmental project team, the following qualifications and attributes are going to be desirable and advantageous in order to successfully compete for the post. -Practical EIA experience within the marine environment and knowledge of regulatory process -A minimum of 2 years marine environment or commercial renewable energy experience -A minimum of 4-5 years environmental consultancy experience -Appropriate qualifications, i.e BSc/MSc -Professional Membership, i.e IEMA, IEEM If you are an environmental consultant and want to work to develop, support and lead a dynamic team of consultants within a consultancy with a reputation for excellence within the energy sector. Then please apply now, or for more information please contact sarah@quanta-consulting.com, 02074264668 http://www.newscientistjobs.com/jobs/job/senior-developerssomersetsouth-coast-renewable-energy-united-kingdom-200643629.htmThu, 19 Nov 2009 10:34:40 +0000192971Senior Developers –Renewable energy Highly successful specialist consultancy, working within the renewable energy industry seek senior development consultants to drive their business forward. Our client has a world renowned reputation for excellence within energy consultancy. Working alongside world leading brands, this really is a fantastic opportunity for a development consultant to progress with the backing of a recognised name. Reporting to the Director of development, you will be part of a team that supports and develops their on & off-shore wind and other renewable technologies consultancy services They are looking for people with excellent project management skills supported by a high level of technical experience and knowledge as this role provides focus and input into various client's projects in the renewable energies market. You will have a proven track record in the renewable energy sector but consideration will be given to people from other energy sectors. Essential: •Min 3 years experience in a commercial renewable energies development environment •Commercial / corporate ethos •Excellent communication skills & client management skills •Strong capability to manage, coach and support team members •An awareness and good understanding of the development issues in the renewable energies market Advantageous: •Detailed understanding of key renewable technologies, either offshore & onshore wind, preferably both •Good understanding of the regulatory processes in Renewables Development •Relevant Professional Membership To apply to this role, or more information on others. Email sarah@quanta-consulting.com or call 0207 4264 668 http://www.newscientistjobs.com/jobs/job/upstream-oil-and-gas-business-development-londonedinburgh-consulting-central-london-west-end-200629159.htmThu, 19 Nov 2009 10:22:26 +0000192933Upstream Oil and Gas Consulting- EMEA region-London Our client is a leading worldwide consultancy specializing in high quality research and analysis to the energy industry. They are presently looking for an experienced upstream oil and gas consultant who will successfully help further develop and increase revenues and profitability for their EMEA business region. You will be expected to further network within the IOC and NOC community, work with other teams across all global offices, contribute significantly to their internal thought leadership and work with teams delivering on projects. Key requirements: •Successful track record in winning consultancy work in the upstream oil and gas sector across the EMEA regions •Experience in project delivery. •Strong presentation skills •Experience in building credible senior management & board level relationships. •Knowledge of the Gas and power sector is advantageous Please apply now or for further information please contact Sarah Green at Quanta Consulting on 0207 4254 667. http://www.newscientistjobs.com/jobs/job/regulatory-affairs-officer-south-east-200636407.htmWed, 11 Nov 2009 13:54:50 +0000178646Regulatory Affairs Officer - Emerging Markets Ref: 16013 Salary: to £40K + bens Based: Middlesex Our client is a global biotech and drug discovery organisation. As a result of on going success they are now seeking to recruit a Regulatory Affairs Officer to assist and support region specific regulatory strategies. Working with regional and affiliate offices you will contribute to, and provide delivery feedback on, region specific regulatory strategies and activities for new products. This will include the preparation of chemistry manufacturing and control (CMC) elements for these emerging markets ranging from market authorisation to post approval processes and renewals. The ideal candidate will be able to demonstrate recent and broad regulatory affairs experience or quality compliance within the pharmaceutical / biotech industry. Experience of providing technical support for the creation, review and finalisation of market applications for regional submissions is required, experience of product registration within emerging markets eg Central/Eastern Europe, MEA, Latin America and Asia Pacific would be advantageous. http://www.newscientistjobs.com/jobs/job/regulator-affairs-manager-south-east-200636406.htmWed, 11 Nov 2009 13:54:46 +0000178645Regulatory Affairs Manager - Emerging Markets Ref: 16014 Salary: to £50K + bens Based: Middlesex Our client is a global biotech and drug discovery organisation. As a result of on going success they are now seeking to recruit a Regulatory Affairs Manager to implement region specific regulatory strategies. Working with regional and affiliate offices you will manage region specific regulatory strategies and activities for new products. This will include the management and delivery of chemistry manufacturing and control (CMC) elements for these emerging markets ranging from market authorisation to post approval processes and renewals. The ideal candidate will be able to demonstrate recent and in depth regulatory affairs experience or quality compliance within the pharmaceutical / biotech industry. Experience of providing technical and managerial support for the creation, review and finalisation of market applications for regional submissions is required, experience of product registration within emerging markets e.g. Central/Eastern Europe, MEA, Latin America and Asia Pacific would be advantageous http://www.newscientistjobs.com/jobs/job/regulatory-affairs-manager-south-east-200633461.htmFri, 06 Nov 2009 16:47:52 +0000172877Regulatory Affairs Manager A TOP biotechnology company based in the South East, are looking to recruit a Regulatory Affairs Manager for their friendly team. If you have demonstrable experience of working in a similar role this should be your next career move! Purpose: Reporting into the Director of regulatory affairs, you will have responsibility for the management of day to day EU regulatory operations and of the support of US regulatory activities within the organisation as appropriate. Major Responsibilities: -Act as the key contact for the communication with the European regulatory agencies in regard to the preparation and the submission of CTA's, MAA, the Scientific Advice, variations, PSUR and Orphan Drug documentation. - develop and implement sound preclinical, clinical and CMC European regulatory strategies that support the clinical and commercial development of new products. - Manage the assembly and internal review of these submissions. Assure that all submissions meet the highest regulatory standards. - Serve as the European Regulatory Affairs representative on project teams, interpreting issues and advising the project team on the application of European regulations, EU regulatory review processes and submission requirements. - Manage day to day EU regulatory activities of 1-2 regulatory associates to assure that the initiation, maintenance and EU CTA's, IMPD, MAA and annual reports are EU compliant. Experience and Education - Bachelors, Masters or Doctoral degree in the appropriate scientific disciplines or a undergraduate or graduate degree in Pharmacy - Significant exposure to working within a pharmaceutical company, EU regulatory agency or with a regulatory CRO, experienced in preparation of regulatory documents for CTA's, MAA, PSUR, Scientific Advice, Orphan Drugs and EU Pharmacovigilance - Computer literate with experience in Microsoft software suite & other relevant packages. Language Skills Fluent in written and spoken English. Multi-lingual capabilities would be a distinct advantage in dealing with CRO's. Keywords: Regualtory Affairs Manager, Regulatory Affairs, biotechnology, EU Regulatory, CTA, MAA, PSUR, Orphan Drugs, CMC, submissions, European Regulatory, variations, European regulations, South East, London, Surrey, Buckinghamshire, Berkshire, Oxfordshire, Hertfordshire We are dedicated to the clinical research industry, offering candidates a unique service including our free \"Pipeline Watch\" career advisory consultation. To find out more call us on 0118 9594990 or email apply@clinicalprofessionals.co.uk http://www.newscientistjobs.com/jobs/job/regulatory-affairs-labelling-manager-switzerland-200633410.htmFri, 06 Nov 2009 16:47:20 +0000172880Regulatory Affairs Labelling Manager - Switzerland - Permanent Our client is a global speciality Pharmaceutical company with a broad variety of products on the market and in late phase development. They are currently seeking a Regulatory Affairs Labelling Manager to join their friendly team. Key Responsibilities: * Develop the optimum labelling strategy for a range of products * Develop and manage processes for the creation, in-house approval and implementation of labelling documents * Organise and lead the cross-functional Global Labelling Team to reach consensus on global labelling matters and the preparation of supporting documents * Coordinate and manage projects on a tmely manner * Support the global implementation including guidance and advice to affiliates and partners. QUALIFICATIONS COMPETENCES Essential * Professional technical training in the field of pharmaceutics, chemistry, biology or other life sciences or university diploma * Experience in the field of International regulatory affairs and/or the pharmaceutical industry * Ability to work in a computerized environment, with good knowledge of Microsoft Office, Internet, databases etc Preferred * Expertise in a registration discipline such as toxicology, safety, efficacy and or/labelling * German Language skills Key Words: Global labelling, labelling, regulatory affairs, regulatory affairs manager, pharmaceuticals, labelling strategy, regulatory projects, Switzerland, European, Europe, german We are dedicated to the clinical research industry, offering candidates a unique service including our free \"Pipeline Watch\" career advisory consultation. To find out more call us on 0118 9594990 or email apply@clinicalprofessionals.co.uk http://www.newscientistjobs.com/jobs/job/regulatory-affairs-consultant-international-expansion-london-200633385.htmFri, 06 Nov 2009 16:46:31 +0000172874Regulatory Affairs Consultant - International Expansion, London, 12 month contract Do you want to work for in an International Regulatory Affairs function that has experienced significant growth in the last 3 years? Do you have strong emerging markets / International expansion experience? Are you at Manager level? If so, then this could be the role for you. Working on a 12 month contract you will be responsible for providing consultant support at Manager level within the International Regulatory Affairs function. You will be responsible for: * Developing and implementing effective regulatory strategies * Registering products in the Middle East/Africa, European, Asia Pacific and Latin American regions * Mentoring and coaching supporting staff The ideal candidate will have a broad understanding of European and International regulations, procedures and guidelines. If this role is of interest please contact Vicky O'Mara on 01189 594 990 or email vmara@clinicalprofessionals.co.uk Key Words: Regulatory Affairs Consultant International Contract Regulatory Affairs Manager London Middlesex Berkshire Buckinghamshire Relocatable We are dedicated to the clinical research industry, offering candidates a unique service including our free \"Pipeline Watch\" career advisory consultation. To find out more call us on 0118 9594990 or email apply@clinicalprofessionals.co.uk http://www.newscientistjobs.com/jobs/job/out-licensing-manager-europe-netherlands-200633325.htmFri, 06 Nov 2009 16:45:37 +0000172869Out Licensing Manager Europe Responsible for the out licencing of my clients products, as well as developing new business opportunities and managing existing relationships in Europe. You will negotiate with their business partners on the licensing terms and successfully conclude contracts. Furthermore, you will provide input for the annual sales planning and forecasting, and develop CRM. The Out Licensing Manager has strong interaction with the pharmaceutical R&D, Regulatory Affairs and Intellectual Property departments within my clients site. You will report to the Vice-President Marketing & Sales. * a Master degree in chemistry, pharmacy, biology or related subjects; * at least 5 years of relevant commercial experience; * experience in (generic) pharmaceutical or related industry; * experience in making market analyses; * outstanding command of the English language. Cv in confidence to ciara@clincialprofessionals.eu +44 207 812 0676 We are dedicated to the clinical research industry, offering candidates a unique service including our free \"Pipeline Watch\" career advisory consultation. To find out more call us on 0118 9594990 or email apply@clinicalprofessionals.co.uk http://www.newscientistjobs.com/jobs/job/drug-safety-associate-south-east-200633317.htmFri, 06 Nov 2009 16:45:09 +0000172797Drug Safety Associate Term: 12 months Rate: £flexible Location: Home Counties Our client are a leading company specialising in pharmaceutical research and development. They are looking to expand Drug Safety team, and looking for a Drug Safety Associate on an 12 month contract which can either be as a permanent employee of Clinical Professionals or freelancing. Purpose of the Role * Triage of incoming cases and prioritizing seriousness * Confirmation of Safety Coordinator case registry data * Database searches as necessary * Completion of literature searches when required * Completion of risk and quality (label, approval, manual coding and quality review steps). * Single case unbinding * Completing protocol request forms as necessary * Discuss source documents and coding ad-hoc queries with the medical physicians. * Completion of remaining case data entry, including narrative or auto-narrative Requirements * Graduate with life science or healthcare degree and proven relevant industry experience within Pharmacovigilance. (Minimum of 6 Months experience). * Understanding of the importance of Pharmacovigilance in ethical pharmaceutical marketing and development. * Use of MS Office products to a competent standard - Word, Excel, Powerpoint. If this role is of interest please contact Jay Sehmi on 01189 594 990 or email with your CV to jay@clinicalprofessionals.co.uk Key words: Periodic safety update reports safety signal detection clinical pharmaceutical biotechnology medical devices CRO clinical trials clinical development pharmacology health medical research drug safety Pharmacovigilance adverse event reporting aris g Arisg PSUR adverse event case processing ADR data physician GMC QP narrative Argus SAE reconciliation safety PV DS PVG PVO SUSARs SARs We are dedicated to the clinical research industry, offering candidates a unique service including our free \"Pipeline Watch\" career advisory consultation. To find out more call us on 0118 9594990 or email apply@clinicalprofessionals.co.uk http://www.newscientistjobs.com/jobs/job/drug-safety-associate-south-east-200633284.htmFri, 06 Nov 2009 16:44:45 +0000172801Recruiter Login Job Search Contact us Client Home My emedcareers   if(evaluateCLLICookie()) { printConsultantBarEC( 'http://www.emedcareers.com', 'emedcareers.com' ); } else { printJobHunterBarEC( 'http://www.emedcareers.com', 'emedcareers.com' ); } Welcome, please register or sign in printAdditionalTabs( 'http://www.emedcareers.com' ); Previous Vacancy | Next Vacancy Return to search results Drug Safety Associate var addthis_pub="jobsiteuk";var addthis_options = 'print, favorites, facebook, myspace, twitter, linkedin, delicious, more'; Drug Safety Associate Term: 12 months Rate: £flexible Location: Home Counties Our client are a leading company specialising in pharmaceutical research and development. They are looking to expand Drug Safety team, and looking for a Drug Safety Associate on an 12 month contract which can either be as a permanent employee of Clinical Professionals or freelancing. Purpose of the Role * Triage of incoming cases and prioritizing seriousness * Confirmation of Safety Coordinator case registry data * Database searches as necessary * Completion of literature searches when required * Completion of risk and quality (label, approval, manual coding and quality review steps). * Single case unbinding * Completing protocol request forms as necessary * Discuss source documents and coding ad-hoc queries with the medical physicians. * Completion of remaining case data entry, including narrative or auto-narrative Requirements * Graduate with life science or healthcare degree and proven relevant industry experience within Pharmacovigilance. (Minimum of 6 Months experience). * Understanding of the importance of Pharmacovigilance in ethical pharmaceutical marketing and development. * Use of MS Office products to a competent standard - Word, Excel, Powerpoint. If this role is of interest please contact Jay Sehmi on 01189 594 990 or email with your CV to jay@clinicalprofessionals.co.uk Key words: Periodic safety update reports safety signal detection clinical pharmaceutical biotechnology medical devices CRO clinical trials clinical development pharmacology health medical research drug safety Pharmacovigilance adverse event reporting aris g Arisg PSUR adverse event case processing ADR data physician GMC QP narrative Argus SAE reconciliation safety PV DS PVG PVO SUSARs SARs We are dedicated to the clinical research industry, offering candidates a unique service including our free \"Pipeline Watch\" career advisory consultation. To find out more call us on 0118 9594990 or email apply@clinicalprofessionals.co.uk http://www.newscientistjobs.com/jobs/job/drug-safety-associate-south-east-200633277.htmFri, 06 Nov 2009 16:44:37 +0000172800Recruiter Login Job Search Contact us Client Home My emedcareers   if(evaluateCLLICookie()) { printConsultantBarEC( 'http://www.emedcareers.com', 'emedcareers.com' ); } else { printJobHunterBarEC( 'http://www.emedcareers.com', 'emedcareers.com' ); } Welcome, please register or sign in printAdditionalTabs( 'http://www.emedcareers.com' ); Previous Vacancy | Next Vacancy Return to search results Drug Safety Associate var addthis_pub="jobsiteuk";var addthis_options = 'print, favorites, facebook, myspace, twitter, linkedin, delicious, more'; Drug Safety Associate Term: 12 months Rate: £flexible Location: Home Counties Our client are a leading company specialising in pharmaceutical research and development. They are looking to expand Drug Safety team, and looking for a Drug Safety Associate on an 12 month contract which can either be as a permanent employee of Clinical Professionals or freelancing. Purpose of the Role * Triage of incoming cases and prioritizing seriousness * Confirmation of Safety Coordinator case registry data * Database searches as necessary * Completion of literature searches when required * Completion of risk and quality (label, approval, manual coding and quality review steps). * Single case unbinding * Completing protocol request forms as necessary * Discuss source documents and coding ad-hoc queries with the medical physicians. * Completion of remaining case data entry, including narrative or auto-narrative Requirements * Graduate with life science or healthcare degree and proven relevant industry experience within Pharmacovigilance. (Minimum of 6 Months experience). * Understanding of the importance of Pharmacovigilance in ethical pharmaceutical marketing and development. * Use of MS Office products to a competent standard - Word, Excel, Powerpoint. If this role is of interest please contact Jay Sehmi on 01189 594 990 or email with your CV to jay@clinicalprofessionals.co.uk Key words: Periodic safety update reports safety signal detection clinical pharmaceutical biotechnology medical devices CRO clinical trials clinical development pharmacology health medical research drug safety Pharmacovigilance adverse event reporting aris g Arisg PSUR adverse event case processing ADR data physician GMC QP narrative Argus SAE reconciliation safety PV DS PVG PVO SUSARs SARs We are dedicated to the clinical research industry, offering candidates a unique service including our free \"Pipeline Watch\" career advisory consultation. To find out more call us on 0118 9594990 or email apply@clinicalprofessionals.co.uk http://www.newscientistjobs.com/jobs/job/drug-safety-associate-south-east-200633271.htmFri, 06 Nov 2009 16:44:22 +0000172793if(evaluateCLLICookie()) { printConsultantBarEC( 'http://www.emedcareers.com', 'emedcareers.com' ); } else { printJobHunterBarEC( 'http://www.emedcareers.com', 'emedcareers.com' ); } Welcome, please register or sign in printAdditionalTabs( 'http://www.emedcareers.com' ); Previous Vacancy | Next Vacancy Return to search results Drug Safety Associate var addthis_pub="jobsiteuk";var addthis_options = 'print, favorites, facebook, myspace, twitter, linkedin, delicious, more'; Drug Safety Associate Term: 12 months Rate: £flexible Location: Home Counties Our client are a leading company specialising in pharmaceutical research and development. They are looking to expand Drug Safety team, and looking for a Drug Safety Associate on an 12 month contract which can either be as a permanent employee of Clinical Professionals or freelancing. Purpose of the Role * Triage of incoming cases and prioritizing seriousness * Confirmation of Safety Coordinator case registry data * Database searches as necessary * Completion of literature searches when required * Completion of risk and quality (label, approval, manual coding and quality review steps). * Single case unbinding * Completing protocol request forms as necessary * Discuss source documents and coding ad-hoc queries with the medical physicians. * Completion of remaining case data entry, including narrative or auto-narrative Requirements * Graduate with life science or healthcare degree and proven relevant industry experience within Pharmacovigilance. (Minimum of 6 Months experience). * Understanding of the importance of Pharmacovigilance in ethical pharmaceutical marketing and development. * Use of MS Office products to a competent standard - Word, Excel, Powerpoint. If this role is of interest please contact Jay Sehmi on 01189 594 990 or email with your CV to jay@clinicalprofessionals.co.uk Key words: Periodic safety update reports safety signal detection clinical pharmaceutical biotechnology medical devices CRO clinical trials clinical development pharmacology health medical research drug safety Pharmacovigilance adverse event reporting aris g Arisg PSUR adverse event case processing ADR data physician GMC QP narrative Argus SAE reconciliation safety PV DS PVG PVO SUSARs SARs We are dedicated to the clinical research industry, offering candidates a unique service including our free \"Pipeline Watch\" career advisory consultation. To find out more call us on 0118 9594990 or email apply@clinicalprofessionals.co.uk http://www.newscientistjobs.com/jobs/job/regulatory-affairs-executive-permanent-cambridgeshire-200633469.htmFri, 06 Nov 2009 16:09:28 +0000172723Regulatory Affairs Executive - Permanent Regulatory Affairs Executive - Permanent The Company Our client is an excellent company to work for who provide discovery, development and post-approval services to the pharmaceutical, biotechnology industries and various other organisations.They are currently looking for a Regulatory Affairs Executive to join their central strategic regulatory team in South East of England. The Role As a Regulatory Affairs Executive you will be provide regulatory advice and carry out projects in the provision of regulatory affairs services. You will liaise with internal and external clients in the provision and marketing of those services. Duties and Responsibilities *To provide project specific regulatory services and co-ordination of these projects. *To provide regulatory strategy advice to internal and external clients. *To assist in business development and pricing of projects for Regulatory Affairs in the company. *To review and prepare regulatory submissions in EMEA & Asia Pacific. *To provide regulatory advisory and training service for regulatory affairs in the company. *To train a small group of regulatory professionals and/or regulatory consultants as appropriate. *To assist in budgeting. Qualifications and Experience *Degree in Pharmacy or Life Sciences, a higher qualification in a relevant subject and/or post-graduate courses in Regulatory Affairs would be an advantage. *Good knowledge of the European/ROW Regulatory Affairs Procedures. *Proven ability to work effectively in a team. *Good knowledge of the European country specific clinical trial application procedures. *Knowledge of ICH and regulatory guidelines in Europe/ROW. *Suitable level of experience within a broad range of Regulatory Affairs projects, a good knowledge of Regulatory Affairs in Europe especially the UK and/or European clinical trials procedures. Keywords: Regulatory Affairs Regulatory Affairs Executive Regulatory Strategy CRO International Clinical Trial Applications ROW/European European Relocatable Regulatory Advice Regulatory Submissions Cambridgeshire Hertfordshire Middlesex Relocatable. We are dedicated to the clinical research industry, offering candidates a unique service including our free \"Pipeline Watch\" career advisory consultation. To find out more call us on 0118 9594990 or email apply@clinicalprofessionals.co.uk http://www.newscientistjobs.com/jobs/job/regulatory-affairs-manager-london-200633467.htmFri, 06 Nov 2009 16:09:14 +0000172721Regulatory Affairs Manager Regulatory Affairs Manager A market leading Pharmaceutical company based in London are currently seeking a Regulatory Affairs Manager to plan, manage and execute regulatory activities to regarding compliance to Competent Authority regulations. They will be accountable for maintaining current knowledge of applicable relevant regulations and guidelines, managing regulatory submissions, conducting meetings with regulatory authorities and keeping Medical, CMC and Regulatory Affairs employees abreast of changes to regulations and the impact on corresponding procedures. It is essential that applicants can demonstrate a solid history within Regulatory Affairs as well as previous experience in regulatory submissions. They must possess understanding of drug Development and Good Clinical Practices (GCP) as well as a working knowledge of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) as they apply to a pharmaceutical research and production environment. Key Words: Oncology, Research and Development, Regulatory Affairs, RA, London South East, Pharmaceutical, Hertfordshire, North London, West London, Relocatable, Middlesex ,CNS, C, CTAs, MAAs, European Procedures, Regulatory Affairs Manager, Regulatory, Regulatory Affairs, Regulatory Manager We are dedicated to the clinical research industry, offering candidates a unique service including our free \"Pipeline Watch\" career advisory consultation. To find out more call us on 0118 9594990 or email apply@clinicalprofessionals.co.uk http://www.newscientistjobs.com/jobs/job/regulatory-affairs-executive-east-sussex-200633465.htmFri, 06 Nov 2009 16:09:04 +0000172719Regulatory Affairs Executive Regulatory Affairs Executive/Senior Executive Interim - 6 months The Company Our client is an excellent company to work for who provide discovery, development and post-approval services to the pharmaceutical, biotechnology industries and various other organisations.They are currently looking for a Regulatory Affairs Executive/Senior Executive to join their central strategic regulatory team in South East of England. The Role As a Regulatory Affairs Executive/Senior Executive you will be provide regulatory advice and carry out projects in the provision of regulatory affairs services. You will liaise with internal and external clients in the provision and marketing of those services. Duties and Responsibilities *To provide project specific regulatory services and co-ordination of these projects. *To provide regulatory strategy advice to internal and external clients. *To assist in business development and pricing of projects for Regulatory Affairs in the company. *To review and prepare regulatory submissions in EMEA & Asia Pacific. *To provide regulatory advisory and training service for regulatory affairs in the company. *To train a small group of regulatory professionals and/or regulatory consultants as appropriate. *To assist in budgeting. Qualifications and Experience *Degree in Pharmacy or Life Sciences, a higher qualification in a relevant subject and/or post-graduate courses in Regulatory Affairs would be an advantage. *Good knowledge of the European/ROW Regulatory Affairs Procedures. *Proven ability to work effectively in a team. *Good knowledge of the European country specific clinical trial application procedures. *Knowledge of ICH and regulatory guidelines in Europe/ROW. *Suitable level of experience within a broad range of Regulatory Affairs projects, a good knowledge of Regulatory Affairs in Europe especially the UK and/or European clinical trials procedures. Keywords: Regulatory Affairs, Regulatory Affairs Executive, Senior Regulatory Affairs Executive, Regulatory Strategy, CRO, International, Clinical Trial Applications, ROW/European, European, Relocatable, Regulatory Advice, Regulatory Submissions, Cambridgeshire, Hertfordshire, Middlesex, Relocatable, clinical research, clinical trials, reg affairs, RA, RA executive, reg affairs executive, We are dedicated to the clinical research industry, offering candidates a unique service including our free \"Pipeline Watch\" career advisory consultation. To find out more call us on 0118 9594990 or email apply@clinicalprofessionals.co.uk http://www.newscientistjobs.com/jobs/job/senior-regulatory-affairs-officer-south-east-200633463.htmFri, 06 Nov 2009 16:08:52 +0000172717Senior Regulatory Affairs Officer Salary:-up to £500 p/day Location:- Berkshire Employment type: - 3 month Contract This company are a forward thinking global Pharmaceutical company who are currently looking for a Senior Regulatory Affairs Officer to help run their Regulatory Affairs department for the UK and Ireland. Key Responsibiliites: * Managing of the Regulatory Department, including keeping an overview of all tasks and ensuring coverage of all tasks * Monitoring Regulatory and QA/QC related spend * Ensuring registration of products on the UK and IE markets in collaboration with Global Regulatory Affairs in Denmark * Ensuring maintenance and updating of products licences for the UK and IE markets markets in collaboration with Global Regulatory Affairs in Denmark * Ensure updating and maintaining of the internal SOP system in compliance with UK legislation as well as with company policy * Assist group QA and/or the RP on issues relating to audits, and ensure information Minimum skills and Requirements: * Graduate Level Education * Significant experience in Regulatory Affairs * UK/IRE Regulatory experience * Understanding of/exposure to Quality Assurance and Drug Safety Keywords:- Regulatory Affairs, Regulatory, Senior Regulatory Affairs Officer, Regulatory Affairs Officer, pharmaceuticals, Uk, Ireland, product licences, Quality Assurance, Drug Safety, Berkshire, Oxfordshire, London, South West, Hertfordshire, Surrey, Middlesex, Hampshire, Bedfordshire, Buckinghamshire We are dedicated to the clinical research industry, offering candidates a unique service including our free \"Pipeline Watch\" career advisory consultation. To find out more call us on 0118 9594990 or email apply@clinicalprofessionals.co.uk http://www.newscientistjobs.com/jobs/job/regulatory-affairs-project-manager-south-east-200633462.htmFri, 06 Nov 2009 16:08:47 +0000172716Regulatory Affairs Project Manager The Company A rapidly expanding global pharmaceutical organisation are seeking a Regulatory Affairs Project Manager to join their UK team. Job Summary In this role you will assist the Regulatory Affairs Manager and the UK Regulatory Affairs team in providing regulatory services to customers and clients. You will take responsibiliy for ensuring that registered marketing authorizations and licences undergoing registration are compliant with current regulations and that they meet the company needs. You will obtain and maintain Marketing Authorisation applications for Europe and the rest of the world. Duties and Responsibilities *Act as regulatory Project leader on assigned stages of certain projects by coordinating the regulatory workflow, providing regulatory support to the team *Compile and complete regulatory deliverables (variation applications, marketing authorisation applications, etc) for assigned projects *Supervise regulatory affairs executives within designated project phases Qualifications and Experience * A graduate degree, preferably in a scientific discipline *Experience of EU regulatory procedures required. Dealings with European agencies an advantage * European regulatory experience specifically with MRP/DCP procedures, and a proven track record in running national and MRP submissions within European markets for MAA's and experience of running variation procedures * Ability to prioritize and plan projects and work * Excellent leadership skills Key Words: Regulatory Affairs, Global, Regulatory Affairs Project Manager, London, South East, Relocatable. We are dedicated to the clinical research industry, offering candidates a unique service including our free \"Pipeline Watch\" career advisory consultation. To find out more call us on 0118 9594990 or email apply@clinicalprofessionals.co.uk http://www.newscientistjobs.com/jobs/job/scientific-affairs-manager-south-east-200633453.htmFri, 06 Nov 2009 16:08:04 +0000172710Scientific Affairs Manager Term: Permanent Salary: £53,000 - experience dependant Location: South coast This is an ideal opportunity to join a growing and respected pharmaceutical company in a varied and challenging position. You will be charged with managing a multi-disciplinary group responsible for Regulatory Affairs, Medical Information, Quality Assurance and Pharmacovigilance. Duties: - Manage the multi-disciplinary group. - Help oversee reorganising of Medical Information and Regulatory Affairs departments top provide a more flexible service. - Depending on experience, deputise for the Medical Director in case of absence. Requirements: - Several years in pharmaceutical industry with experience in one or more of the above areas but an interest in all. - Ideally experienced in management. Key words: clinical pharmaceutical biotechnology medical devices CRO clinical trials clinical development pharmacology health medical research drug safety pharmacovigilance GMC QP management manager medical director We are dedicated to the clinical research industry, offering candidates a unique service including our free \"Pipeline Watch\" career advisory consultation. To find out more call us on 0118 9594990 or email apply@clinicalprofessionals.co.uk