Vice President, Regulatory Affairs (Cell / Tissue Engineering or Gene Therapy)

Location Boston
Discipline: Regulatory Affairs
Job type: Permanent
Salary: £Salary: Negotiable
Contact name: Chris Sinclair

Contact email: chris.sinclair@rbwconsulting.com
Contact phone: 1 617-982-1238
Job ref: 20833(ii)
Published: 26 days ago
Expiry date: 15 April 2021

​Our client is an innovative and growing BioTech looking to achieve something different and unchartered within the Life Science industry! As the first key long-term Regulatory hire in the business, you will be responsible for leading and developing the regulatory strategies that the organization follow to ensure that they are meeting complex industry standards, whilst being the glue to ensure that all stakeholders (internal and external) are kept well informed of progress and challenges.

This role is suited to an individual with strong regulatory strategy experience dealing with the CBER division of the FDA, alongside any experience working with gene or cellular therapies. This opportunity will be for an individual who embraces the challenge to step into a role that is initially hands-on, with the aim to grow a team underneath them moving forwards.

The ideal candidate will:

  • Have at least 10+ years’ experience within Regulatory Affairs.

  • Have experience in the areas of cell and tissue engineering and / or gene therapy.

  • Be experienced in dealing with multiple divisions of the FDA at the same time (especially CBER).

  • Be comfortable navigating unchartered areas within Regulatory Affairs.

  • Understand Quality Assurance & GxP requirements.


If you are keen to learn more about this unique opportunity, then please apply today so that Chris Sinclair at RBW Consulting can review your profile and be in touch to discuss this in more detail.

Salary: Negotiable