Global Regulatory CMC Lead for ATMPs

Reference: OLI260321

Expiry Date: 26-10-2021

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Greater London
United Kingdom

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Job Description

Global Regulatory CMC Lead for ATMPs

We are hiring for a Regulatory CMC Associate Director to join a growing pharmaceutical company based in West Greater London (close to Welwyn Garden City and Hemel Hempstead).

This is a unique opportunity to join the new R&D unit of an already established, global Pharmaceutical company where you can become an integral part of a newly formed and agile team dedicated to gaining approvals for ATMPs targeting unmet medical needs.

Reporting directly into the Head of Regulatory Affairs and Cell Therapy you will be the Global Regulatory CMC Lead, not only for RA CMC strategy but also for health authority interactions/ Scientific Advice Procedures and the preparation of CMC sections of IMPDs and for MAAs.

The Global Regulatory CMC ATMP team is still in its early stages of development and your role will play a key hand in helping to build and develop a strong team able to technically support ATMP’s in both early and late stages development, and due to the size and structure of the department you will have many opportunities to showcase your ATMP CMC strategy and execution skills.

In this role, you will act as the Global Regulatory CMC Lead, working with Global Regulatory Project Teams and external partners  to:

  • Devise and implement the global regulatory CMC strategy for the assigned product/s in order to support early and late stage ATMP’s
  • 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 4-7 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.

This is a rare and exciting opportunity to join the R&D function of a developing franchise in a high-profile role with full project responsibility for RA CMC ATMP products for the EU, Japan and ROW markets.

In return you will receive an excellent base salary, with a good bonus and a LTI plan, working for a global, R&D driven company dedicated to investing and developing its newly formed ATMPs team and pipeline.

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact Theo Moore on +44 (0)207 801 3384 or Oli Dimitrov on +44 (0)207 801 3388 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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