Global Regulatory CMC Manager or Snr Manager – Biologics, NBEs *** Gain initial BLA/MAA exp., UK

Reference: Oli10481CR1

Expiry Date: 31-12-2020

Category Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
Maidenhead
Windsor and Maidenhead
United Kingdom

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Job Description

Global Regulatory CMC Manager or Snr Manager – Biologics, NBEs *** Gain initial BLA/MAA exp.

We are hiring for a Manager or Senior Manager Regulatory CMC to join a growing biopharmaceutical company based in the M4 Corridor of Berkshire, UK.

This is a unique opportunity to join this company at a pivotal stage in its history. With over 20% of turnover reinvested in R&D, a busy pipeline of early and late stage development projects, several business acquisitions recently and plans to invest heavily in the UK – this is a company that offers more than just interesting projects to work on. You will become an integral part of an organization that will provide you with the necessary environment for personal and professional growth.

This role is for you to consider if you want to:

  • Work in a company that is growing, financially healthy and has a successful track record in developing and marketing novel molecules.
  • Work in an international, matrix environment with experienced GRLs who have great deal of experience developing people.
  • Want to gain more M3 build experience, including authoring and re-authoring of sections for QoS and M3 for first/initial MAA/BLAs.
  • Learn how to develop Regulatory CMC strategy in time.
  • Work in a global team where you can gain more EU and US experience.

Who’s right for the job?

  • My client is offering Manager or Senior Manager grading for this role, so you may be a professional with 2-4 or 4-7 years of Regulatory CMC Biologics experience. You may have analytical development, process development or bio manufacturing experience previously and now want to consolidate and develop your regulatory career.
  • You would have worked in a Regulatory CMC Bio function, authoring and re-authoring Module 3 for mAbs, other proteins, ATMPs etc.
  • You might be an RA CMC individual who has early to late stage development experience authoring IMPDs, INDs, Scientific Advice preparation etc.
  • You would have experience managing CMC aspects of Health Authority questions.

Package & Bens

My client offers a competitive salary, 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 and is one of the first of our clients to recruit and on-board digitally at the start of the pandemic.

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 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.

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 SARS-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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