Hobson Prior are looking for a Senior Regulatory Affairs Manager to join a brilliant pharmaceutical corporation on a permanent basis located in London. Our Client is focused on cooperating with other agencies to evolve innovative technology.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• For this role, you will Maintain an up to date understanding of changes in regulations, CMC and GMP requirements for ATMPs in order to stay up to date.
• Prepare regulatory documents (briefing documents, IMPDs, CTAs, INDs, amendments, safety reports, annual reports, etc.) according to business needs and agreed-upon time, cost, and quality parameters.
• Ensure that all incoming proposals and external proposals are subject to appropriate regulatory due diligence.
• Assist in the development of strategies to influence regulators on appropriate risk evaluation and management by developing constructive working relationships with Competent Authority and Health Authority contacts.
• Management, including delegation of key responsibilities.

Requirements:

• At least 5+ years of proven experience in a regulatory role relating to advanced therapy medicines as well as experience with regulatory affairs.

Apply now:

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.