Senior Manager Regulatory Affairs CMC – lead submissions for NBEs, UK, M4 Corridor
We are recruiting for a Snr Manager Regulatory Affairs CMC to lead projects in development for a leading biopharmaceutical company in the South East.
This is a permanent role for a Senior Manager Regulatory CMC, leading submissions for NBEs in the EU and the rest of the world.
Who is our client?
Our client is a fast-moving, international Biotechnology company, now expanding their Regulatory Affairs CMC team across the world. They are a global, R&D driven business that has over the years pushed the boundaries of what is possible in order to transform patients’ lives. This company invests heavily in cutting-edge scientific research, it supports is people and produces successful drugs that make real difference to people around the world.
What will your duties be?
- Lead as assigned large molecule projects in development providing regional strategic and operational Regulatory CMC expertise.
- Write and review global and regional Regulatory CMC submission documents, IMPDs, MAAs etc.
- Manage CMC aspects of Health Authority questions.
What is there for you?
- Become part of a highly successful Biotechnology company that nurtures a team culture of mutual respect and support.
- Work on variety of projects in development, supporting drugs in Ph2 and Ph3.
- The location is easily commutable by train from London and Reading and is easily accessible via car with company car parking on premises.
- Flexible working hours are available and the role comes with competitive salary, bonus and lucrative stock plan.
What do you need to bring to the table?
- It is essential to have at least 5 years of Regulatory Affairs CMC experience supporting and authoring dossiers for mAbs, vaccines, recombinant proteins, Cell & Gene Therapies or ATMP’s.
- Experience in successful authoring and compiling of IMPDs for biological products as well as MAA, Module 3 experience.
- Experience of direct communication with the Health Authorities.
- Demonstrated leadership, communication skills and emotional intelligence.
To apply, please send a full CV to CV@AdvTalent.com, or alternatively contact Oli or Theo on +44 (0)207 801 3388 or +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.