Regulatory Affairs CMC – late stage projects, gain initial MAA/NDA experience, home 2 days per week, UK

Reference: Oli10493J

Expiry Date: 12-11-2021

Category Regulatory Affairs

Salary: On Application

Job Type: Full Time

Windsor and Maidenhead
United Kingdom

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Job Description

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!

To apply for this role, please press the red “Apply for position” button, or contact Oli Dimitrov on +44 (0)207 801 3388 or Theo Moore on +44 (0)207 801 3384. All applications are received in confidence! ADV Talent Partners will help you each and every step of the way through the hiring process!

Note: My client has committed to do digital hiring using Skype (VC), and has 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.

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