Global Regulatory CMC Lead – ATMPs, Netherlands with relo

Reference: OLI171220UKNLR

Expiry Date: 22-03-2021

Category Regulatory Affairs

Salary: On Application

Job Type: Full Time

Greater London
United Kingdom

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Job Description

We are hiring for an Associate Director Regulatory CMC ATMPs, to join a growing pharmaceutical company based in the Netherlands - relocation package offered.

This is a unique opportunity to join this global pharmaceutical company and become an integral part of a newly formed and agile team dedicated to gaining approvals for ATMPs, targeting unmet medical needs. This is a high-profile role in this organisation where you will provide regulatory CMC strategic advice as well as hands on document preparation support, in order to achieve successful submissions of CTA and MAA applications in the EU and possibly China and Japan.

What is the job?

In this role, you will act as the Global Regulatory CMC Lead, working with the Global Regulatory Project Team as well as CROs and other partner organisations to:

  • Devise and implement the global regulatory CMC strategy for the assigned product/s in order to support late stage CTAs as well as initial MAAs
  • Provide detailed regulatory advice on manufacturing controls and specifications reflecting regional requirements for ATMPs
  • Be responsible for health authority interactions and represent the company at agency meetings
  • Lead the preparation of CMC sections of IMPDs, Scientific Advice Procedures and module 3 for MAAs
  • Select and manage external resources required to achieve regulatory CMC submission success in all regions
  • Support the Manufacturing Lead and Quality Assurance function with the preparation/review of (non)regulatory manufacturing related documentation.

Who’s right for the job?

  • My client is offering an Associate Director grading for this role, so you may be a professional with 5-7 plus years of Regulatory CMC ATMP experience in an EU or Global position. Experience with Japan and China is desirable
  • You would have worked in a Regulatory CMC function, authoring and re-authoring IMPD/INDs and Module 3 for ATMPs as well as tech transfer between regions for Advanced Therapeutics and Scientific Advice preparation
  • You would have experience managing CMC aspects of health authority questions
  • Good working knowledge of the ATMP CRO manufacturing landscape is required
  • Ability to work independently is a must, although you will be part of a collaborative and supportive, non-hierarchical team
  • Confident, succinct written and oral communicator. English is the business language in this company.

Interested in the above? I look forward to hearing from you!

To apply for this role, please press the red “Apply for position” button, or contact me 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.

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