Senior CMC Regulatory Manager * Have you IMPDs for Bio, want 1st BLA exp?

Advanced S&S (USA)
RTP Area, NC
On Application
Closing date
14 Oct 2020

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Regulatory Affairs, CMC, Compliance
Full Time
Contract Type
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Senior CMC Regulatory Manager * Have you IMPDs for Bio, want 1st BLA exp?

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.

Senior RA CMC Manager (NBEs / Biologicals in development): Have you worked with biologicals or vaccines, or recombinants, and want to work in a pure development CMC regulatory role, with your own project accountabilities for the US region?


This role is based in Durham / RTP / Raleigh area, North Carolina. The company will consider relocation for compelling individuals.

About the Opportunity

You might be working with a regulatory consultancy, or in a small bio-pharma or larger company, and find the work too operational? You might be wanting to now step up and develop your own programs’ RA strategies for the US region, for NBEs in Ph 1-3 with the support of a GRL for RA CMC, for a number of compounds (mAbs / gene therapies mostly).

Most of all, you will want to work in a company which really strikes me as standing out, has a super polished culture, with a ‘can do’ approach, and, if you read their postings in Café Pharma, you will see ‘dynamic’ and ‘fast-moving’ come up time and time again. You will have your own project accountabilities, in a company where strategy is aggregated not dictated.

The company is a highly successful and innovative bio-pharma (they have several blockbuster patient assets) with a reputation for delivery of ground-breaking therapies, and has one of the best ‘profitability per employee’ ratios around.

I do work with other biopharma’s and Pharma’s who produce a third less revenue, with much more headcount, and my client’s successes comes down to their approach to R&D - their commitment to 1st in Class Molecules - and most importantly their innovation and creativity of their employees. The senior leadership is tried and tested, and the role reports locally to a decent team director who has helped many individuals up through the ladder through merit.

Skills & Experience

To apply for this role you will:-

  • Be able to devise US region regulatory CMC plans for NBEs in development, review plans on an ongoing basis and collaborate for your assigned NBEs with the CMC sub-teams
  • Have a foundation in a previous role of authoring regulatory CMC dossiers and responses to questions from health authorities
  • Have a strong understanding through Masters or PhD and / or work experiences in biologicals, either recombinants, gene therapies, f/m/Abs, or plasmids
  • Able to work in a multi-national and multi-cultural global matrix; support initiatives by taking part in workstreams; be a positive contributor at the project and team level.

Package & Incentives

Fairly uniquely in the US, they offer Senior Managers a high performing stock scheme, as well as a decent bonus scheme and decent medical / insurances, an all-round package for incentivising performance. If you work for top 10 Pharma’s, a CRO or a smaller companies, you will find their salaries higher than you might expect.

To Apply!

To apply, please contact Matt or Theo on 855.505.1382 to find out more about this role and other available positions we have. Alternately, please send me a full CV to and I will respond to you by return.

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 team know our 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
  • +1 855-505-1382
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