Regulatory Affairs Manager - Central London - Full project lifecycle role!
Regulatory Affairs Manager - Central London - broad based role covering CTA’s, MAA’s, regulatory strategy, labelling, and work on new development projects as they come through the pipeline.
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.
They are committed to digital hiring using Skype (VC), and have a new digital on-boarding and induction training process in place to allow a smooth transition during MERS-COV-2 outbreak. During the next period, new hires will be allowed to work from home full-time, until such a time occurs when normal working returns.
As Regulatory Affairs Manager you will be responsible for complex scientific development and 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 and in the longer term you will working on development projects supporting and late stage projects covering PIP’s, CTA’s, Scientific Advice & MAA’s.
You will find many great things about this role, the team, the culture, the projects and the opportunity for personal and professional growth - this is an environment and company where you are expected to develop and grow your expertise, become more senior, and take on more responsibility!
The salary for this role is very good 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:
- Experience of CTA’s and/or working on projects in development
- Experience of post-marketing regulatory affairs, including variations and life cycle management through European procedures (CP, DCP, MRP)
- 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, please send a full CV to CV@AdvTalent.com, or alternatively contact Theo 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.