Regulatory CMC Senior Manager - Bio, pure development role, have mAbs or recombinants? Gain Cell & G

Employer
Advanced Regulatory (UK & Europe)
Location
Berkshire, UK
Salary
Competitive
Closing date
14 Oct 2020

View more

Discipline
Regulatory Affairs, CMC, Compliance, Project Management, Regulatory Project Management
Hours
Full Time
Contract Type
Permanent
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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.

Hiring Process

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!

To apply, please send a full CV to CV@AdvTalent.com, or alternatively contact Matt Greig  or Oli Dimitrov on +44 (0)207 801 3386 or +44 (0)207 801 3388. 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.

Advanced Regulatory is a new recruitment organisation. Our consultants are industry known and highly experienced in Regulatory Affairs recruitment. We have assembled a team with competencies in databased contingency recruitment, Search & Selection as well as Creative & Campaign management. Our specialism is Regulatory Affairs. We know that successful submissions are underpinned not by one but many people, all working in cohesion. Whether you require a new career position or a new recruit at junior, mid or senior level, we would like to assist you. Our remit is to provide Regulatory Affairs professionals at all levels to pharmaceutical, regulatory consulting, biopharmaceutical and clinical research organisations.

Contact Us
  • Suite 8 Penhurst House
  • 352-356 Battersea Park Road
  • SW11 3BY
  • GB
  • +44 (0)20 7801 3380
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