Senior Regulatory CMC Manager * Have you IMPDs for Bio, want 1st BLA exp? (code USA 170120-3)

Reference: MG170120D

Expiry Date: 30-06-2021

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Middlesex County
United States

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Job Description

Senior Regulatory CMC 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 the Cambridge / Boston area in Massachusetts. 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 for this role, please press the red “Apply for position”, or contact Matt or Theo on 855.505.1382. We wish you a successful 2020 and fortuitous year! 

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