CK Clinical is recruiting for an Associate Director, Regulatory Affairs to join Boyd Consultants. The role will specialise within medical devices and companion diagnostics and will be part-time (3 days per week). Boyds are a consultancy providing a wide range of expertise and skills central to the development of pharmaceutical and biotechnology medicinal products and medical devices. Working with early stage biotechs, medical device companies and universities, the team supports the development of advanced therapy medicinal products (ATMPs), small molecules and biologics across a wide range of therapeutic areas. This role will be as their medical device and companion diagnostic expert. Flexible working is offered with a choice of offices to work from if desired. Their sites are in Dublin, Cambridge or Crewe.
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 for companion diagnostics and novel devices.
- Providing global regulatory diagnostics strategic advice to clients including EU and US.
- Preparing and submitting high-quality regulatory documents including but not limited to, CE documentation, US Q-submissions, US premarket approvals (PMAs) and notifications (post approval reports, annual reports, establishment registration and device listings).
- When required, input into the review of documentation to support gene therapy submissions, including, but not limited to, IMPD/CTA/IND, scientific advice briefing documents, orphan drug applications, PIPs/PSPs, MAA/BLA, responses to questions and other regulatory filings to support regulatory compliance.
- Remain expert and up to date on global Companion Diagnostic regulatory requirements.
- Lead regulatory agency interaction and negotiations.
- Be a leader in developing new procedures/processes for complex ATMPs.
- At least a Life Sciences degree.
- Significant experience in medical device regulatory affairs with some experience in Companion Diagnostics and ATMPs is strongly preferred
- Extensive experience leading the development of Regulatory Strategy.
- Strong experience with EU and/or US submissions and regulations.
- Experience with IVD regulatory submissions including CE-marking, IDE, PMA, Pre-submissions. Experience with IVDR Technical Documentation an advantage.
- Self-starter with the ability to independently find creative solutions for complex problems. A strong customer focus with a flexible approach to work and a willingness to share ideas and experiences
Entitlement to work in the UK is essential. Please quote reference 50106 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group
- Contact: Julia Day
- Phone: 01246 457733
- Reference: 50106
Website: CK Group
- Updated: 31st March 2021
- Expires: 28th April 2021