Regulatory Affairs Manager, Companion Diagnostics
- Experience Level
Hobson Prior are in search for a talented Regulatory Affairs Manager, Companion Diagnostics to participate in the development and implementation of regulatory strategy at a pioneering biotech organisation.
Please note that to be considered for this role you must have the right to work in this location.
- Accountable to collaborate with the Global Regulatory Gene Therapy RA Lead to implement a successful co-development strategy that bridges across the assigned gene therapy and companion diagnostics.
- Providing input on Companion Diagnostic collaboration projects with external vendors.
- Supports the project teams in implementing the global regulatory diagnostics strategy, which is aligned with the co-development and commercialization strategies of the gene therapy concerned in key markets, including EU and US.
- Keep up to date on global Companion Diagnostic regulatory requirements.
- Ensuring preparation and submission of high-quality regulatory documents including but not limited to, CE documentation, US Q-submissions, US premarket approvals and notifications.
- Act as contact point for internal and external clients, including CROs and regulatory authority interactions.
- Accountable for the regulatory project management for assigned projects i.e. planning and tracking submission and approval timelines, regulatory commitments, etc.
- Contributes to the growth of the function, including creation and review of Standard Operating Procedures and policy guidelines for the regulatory affairs department.
- Keep up-to-date of relevant regulatory intelligence and ensuring this is communicated, appropriately, across the Company.
- Support with training of staff in regulatory matters as required.
- When required, input into the review of documentation to support gene therapy submissions.
- May perform other duties as required or assigned.
- Educated at a relevant degree in a life science / science discipline.
- Prior experience to 6-8 years' in IVD medical device regulatory affairs with some experience in Companion Diagnostics preferred.
- Extensive knowledge of EU and US IVD medical device requirements is essential. Awareness of Japan, Canada and Australia Companion Diagnostic requirements would be a bonus.
- Awareness of IND, NDA/BLA, CTA and MAA as a minimum.
- Experience with IVD regulatory submissions including CE-marking, IDE, PMA, Pre-submissions. Experience with IVDR Technical Documentation an advantage.
- Demonstrated successful interactions and submissions with regulatory agencies including Notified Bodies, FDA and vendors/consultants.
- Previous experience in writing and implementing device Regulatory SOPs a bonus.
- Demonstrated ability to create and drive an effective regulatory strategy and handle critical issues effectively with demonstrated creativity in solving regulatory issues.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.