Regulatory Affairs CMC – late stage projects, gain initial MAA/NDA experience, home 2 days per week
Do you want to work on late stage Phase 3 projects for a set of NCEs with multiple indications? Then this role may be for you.
I am hiring for an international pharmaceutical company which has a successful track record in developing and registering new products. This role is for a Regulatory Affairs CMC professional (Manager / Snr Manager Grade) who wants to gain more experience authoring and re-authoring of CMC sections for initial MAAs as well as NDAs. This is a global role and will help you gain significant EU and US experience.
This role is with a growing company that is financially viable and has recently acquired 2 smaller clinical stage companies, adding several novel small molecules to an already busy pipeline.
This role can be located in the UK (Berkshire, M4 Corridor) or mainland Europe.
What will your duties be?
- You will be working on a late stage Phase 3 programs for a set of NCEs with multiple indications. Authoring and reviewing global and regional Regulatory CMC submission documents (Module 3 for MAA/NDA).
- Lead as assigned projects in providing regional strategic and operational Regulatory CMC expertise.
- Manage CMC aspects of Health Authority questions.
- Have an input in the Regulatory CMC strategy working closely with the leadership team.
What do you need to bring to the table?
- 4 -7 years of Regulatory Affairs CMC experience, with proven track record of writing / authoring Module 3 for MAA/NDA, post approval variations.
- Early stage development experience authoring IMPD/INDs, preparing Scientific Advice will be a plus.
- Experience in direct communication with the Health Authorities on CMC matters.
- Positive, can do attitude, good communication skills as well as project management skills.
Package & Bens
My client is offering Manager or Senior Manager grading, for these positions, including a bonus, and incentives plan. The company is willing to consider individuals that want to work from home for 2 days a week post-Covid. You will receive continual training and mentoring, from individuals with 15-20 years each biologicals and regulatory CMC.
To apply, please send a full CV to Oli@AdvTalent.com, or alternatively contact Oli Dimitrov or Theo Moore 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.
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