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