Regulatory Affairs Director - Biologics

Recruiter
Michael Page
Location
England
Salary
60000.00 - 100000.00 GBP Annual
Posted
02 Dec 2021
Closes
16 Dec 2021
Position/Level
Director
Responsibilities
Strategy
Sector
Government
Contract Type
Permanent
Language
English
I have partnered with a market leading and rapidly expanding consultancy who due to growth are looking for a number to regulatory affairs professionals to join the high performing Regulatory Affairs team.

The role can be remote based in the UK.

Job Description
As Regulatory Affairs Director - Biologics you will independently lead regulatory projects in a client-facing position. This will involve developing regulatory strategy for novel cell and/or gene therapies.

Key duties will include:
  • Providing expert strategic advice to clients, considering regulations and guidelines relevant to their products.
  • Preparation of regulatory submission documents including orphan drug designation applications, scientific advice briefing documents, CTA/INDs, paediatricinvestigation plans, PRIME/BTD and MAA/NDAs.
  • Lead regulatory agency interaction and negotiations.
  • Provide support to the wider business, potentially including mentoring and business development.
  • Be a leader in developing new procedures/processes for complex projects.
The Successful Applicant
Regulatory Affairs Director - Biologics
  • Scientific Degree
  • Proven Regulatory Affairs experience within the pharmaceutical industry and product development.
  • Experience within consultancies is a bonus.
  • Experience working with Cell/Gene Therapies or Biologics is essential.
  • Extensive experience leading the development of Regulatory Strategy. Pre-approval experience is preferred.
  • Strong experience with EU submissions and regulations. US experience is also a bonus.
  • Ability to lead Health Authority interactions.
  • Self-starter attitude, with the ability to independently find creative solutions for complex problems.
What's on Offer
Competitive Salary + Benefits

Contact
Chloe Baverstock

Quote job ref
JN-072797

Phone number

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