Regulatory 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
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