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London, Greater London
Regulatory Affairs Manager - Central London - Varied and Broad based role
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Salary: HASH(0x563cefa20760) |
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Overview
Regulatory Affairs Manager - Central London - Varied and Broad based role Location : Central London, easily commutable from Liverpool Streel, Kings Cross, Victoria, London Bridge, Paddington and Waterloo. My client is a small but expanding global pharmaceutical company with a number of successful recently approved products. They develop products in over 8 different therapy areas and are considered as a growing, dynamic company where everyone is expected to make a real difference. They have a friendly culture and offer real career pathways for those that want to expand their horizons. As Regulatory Affairs Manager you will be responsible for complex scientific post approval projects, working to manage EMA queries and answer questions. With the Regulatory Strategy Lead you will work cross functionally with colleagues in EU, US and Japan to inform and influence. You will support post-marketing licensing requirements and ensure effective liaison across the organisation to optimise regulatory strategies In the short-term you will be working in a broad based role in post-marketing regulatory affairs, for 2 recently approved products but in the longer term as you gain more achievements you will have the opportunity to be involved in new development projects as they come through the pipeline. You will find many great things about this role, it covers most aspects of post-marketing regulatory affairs, including variations and life cycle management through European procedures and you will be working on global teams that includes the EU, US and Japan. You will also be working on clinical, labelling and PV projects, and you will also receive development opportunities to move into pre-approval projects and/or supporting new MAA’s. So you will have the opportunity to be involved in new development projects as they come through. The salary for this role is considered as strong and the benefits package is comprehensive and includes full medical and healthcare, high level pension contribution from the employer, dental, a great holiday allowance, flexible working hours and options to work from home. For this position you will need to have excellent EU post approval experience, this will include: Experience of post-marketing regulatory affairs, including variations and life cycle management through European procedures (CP, DCP, MRP) Experience of clinical, labelling and PV amendments and changes Ability to work well within a matrix environment, build team relationships and interface in a global team environment at all levels of management Proven ability to plan, effectively coordinate and lead activities simultaneously on multiple projects, many with tight time deadlines Ideally some experience in EU regulatory submissions, with specific experience of clinical and non-clinical submissions to Health Authorities. To Apply To apply , please send a full CV to CVAdvTalent.com , or alternatively, contact Theo Moore on 44 (0)207 801 3384 . We are assigned these roles by our client and will provide you with support throughout the hiring process. About Advanced Search & Our Network Advanced Search , has a network of affiliated companies including ADV Regulatory , and ADV Talent Partners . Together, we are specialists in Regulatory Affairs and Life Sciences recruitment especially around mAbs and biologicals for roles in R&D and Commercialization and have been established and hiring in this area since 2005. Our Regulatory Affairs team know their subject matter areas and our mission is to help you grow your career each and every step of the way. We have helped many of today's leading companies develop strong regulatory sciences functions and are known for hiring complimentary teams that work well with each other, at owner-contributor, strategy leading and people management levels. Contact us today to see how we can help you make that next career move on 44 (0)207 801 3380 All applications are kept in confidence and we invite applications from all members of the Academic, Research & Development based bio-pharmaceutical community.