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Regulatory Affairs Manager

Regulatory 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