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Regulatory Affairs Director

Cambridgeshire CB4 0FZ   •  Contract/Temporary, Full time

CK Group are recruiting for a Regulatory Affairs Director to join a company in the Pharmaceutical industry on a contract basis for 6 months. This is a strategically focused role working on one mature oncology project within the EU. This role is fully remote working but must be able to attend site in Cambridge on occasion.
Our client is a global pharmaceutical company with a major presence in the UK. Their purpose is to deliver life-changing medicines and to do this they are completely science-led and like to share this with the scientific, healthcare and business communities within the UK.

This Regulatory Affairs Director role will be based at our clients site in Cambridge.

£515 per day PAYE / £650 per day Umbrella, depending on experience.

Regulatory Affairs Director Role:

  • Accountable for leading the development and implementation of the regional or global regulatory strategy for a product/group of products. Ensures that the strategy is designed to deliver rapid approval with competitive labeling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients.
  • Lead cross-functional Teams in major health authority interactions.
  • Lead a Global Regulatory Strategy Team (GRST) of key contributing members from the regions, emerging markets, RA CMC, Labeling and members of the submission and execution team. Participate in coaching, and performance feedback.
  • May represent Regulatory Affairs on Global Product Teams (GPTs) providing strategic regulatory advice and be accountable for all Regulatory activities.
  • Accountable for the delivery of all regulatory milestones on your team including assessment of the probability of regulatory success based on a thorough assessment of regulatory risks and mitigations. Lead preparation of the regulatory strategy document and target product labelling.

Your Background:

  • An advanced degree in a science related field and/or other appropriate knowledge/experience.
  • At least 5-year experience of regulatory drug development or equivalent, and experience with major Health Authority interactions. Prior experience with phase 3 design including end of phase 2 health authority interactions is desired. Contribution to a regulatory approval including leading response team and labelling negotiations would be a plus.
  • A solid knowledge of regulatory affairs within at least one therapeutic area in early and late development.
  • Experience with oncology or particularly haematology would be highly advantageous.

For more information or to apply for this Regulatory Affairs Director position, please contact CK Group, quoting job ref 49962.

It is essential that applicants hold entitlement to work in the UK.

You must be eligible to work in the UK. Learn more

  • Agency: CK Group
  • Contact: Julie Marshall
  • Phone: 01438 723 500
  • Reference: 49962
  • Posted: 23rd February 2021
  • Expires: 23rd March 2021

CK Group

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