Expiry Date: 29-12-2020
Category Regulatory Affairs
Job Type: Full Time
Regulatory CMC Senior Manager – Bio, pure development role, have mAbs or recombinants? Gain Cell & Gene
Note on Covid: we have hired for this company during Covid, and they are capable of on-boarding you from home, and have a digital hiring process in place.
About my client!
My client is seeking a senior regulatory CMC manager, who has direct experience of working in development CMC with MSAT and manufacturing, to drive CMC plans through the clinical phases, provide IMPDs, and strategies, and help with scale up for Ph 3 from a regulatory perspective, as well as prepare first BLAs (this team does not do lifecycle management).
The role and your skills!
Depending upon your education, the company would consider individuals who have worked with biopharma companies, ideally, or CDMOs in regulatory, who want to work in this development space and have 4-7 years in experience. You will already co-authored regulatory CMC strategy docs for 1 or more region, even if assisting a Director, and have built / reviewed / submitted IMPDs, prepared M3 even if not yet filed, and be aware of the European requirements of a modality which is a biologic and now want to widen your experiences with Cell and Gene Therapy products.
Package & Location
The company offer at Senior Manager level RSU-based stock plans, a car allowance, decent bonus and an above the norm basic salary, and this role is easily commuted from West London, Middlesex, Herts south, Bucks and Berks, as well as West Surrey.
The interviewing process will be managed through MS Team, and the hiring manager has a big degree of credibility and experience to help you nurture your skills and develop into a more senior role with time. The company does have the global and regional leads in Europe. The company will provide home working support during and after Covid, but as things settle down, you will be allowed to work back in the office in time.
To apply for this role, please press the red “Apply for position” button, or contact Matt Greig on +44 (0)207 801 3386 or Oli Dimitrov on +44 (0)207 801 3388 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.
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