Location Cambridge or Crewe
Boyds is looking for an Associate Director, Regulatory Affairs to join its growing team. Boyds provides a wide range of expertise and skills central to the development of pharmaceutical and biotechnology medicinal products and medical devices. We work with ATMPs and orphan medicines across a range of therapeutic areas and this role will be our medical device and companion diagnostic expert. This is a permanent position to join an award-winning Regulatory team. Remote working can be considered, with occasional visits to site in Cambridge or Crewe.
Responsibilities: As Associate Director, Regulatory Affairs you will independently lead projects to develop, review and execute regulatory strategy for clients, and will also take the lead delivering regulatory activities/submissions necessary to support product development and registration.
Key duties will include:
Providing expert strategic advice to clients, taking into account regulations and guidelines relevant to their products.
Preparation of regulatory submission documents including orphan drug designation applications, scientific advice briefing documents, CTA/INDs, paediatric investigation 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 ATMPs.
Qualifications: As Associate Director, Regulatory Affairs you will require:
At least a Life Sciences degree.
Proven Regulatory Affairs experience within the pharmaceutical industry and product development. Experience within consultancies is a bonus.
Experience working with ATMPs is essential.
Extensive experience leading the development of Regulatory Strategy.
Strong experience with EU and US submissions and regulations.
Ability to lead Health Authority interactions.
Self-starter attitude, with the ability to independently find creative solutions for complex problems.
Applications are being handled by our recruitment partner, CK Clinical. For more information, please contact Andy Leake on 01438 842966 or email firstname.lastname@example.org. Please quote reference 50069 in all correspondence.