Hobson Prior is seeking a Regulatory Affairs Manager to join a thriving company in London. The client is a leader in T cell programming technologies and you will be joining the rapidly expanding regulatory team. Your responsibilities will encompass planning, preparing, reviewing and submitting regulatory applications to global health authorities.
Regulatory Affairs (RA) Manager – London
- Support submissions through from planning to review – including clinical trial authorisations, amendments, scientific advice meeting packages, etc
- Project manage for relevant gene therapy products – early to late stage clinical development
- Monitor Advanced Therapy Investigational Medicinal Product (ATIMP) therapies to ensure correct procedures are being followed
- Carry out ICH GCP compliant reviews for technical documents
- Engage in technical authoring as necessary
- Liaise with external providers cross-functionally to guarantee high quality and timely regulatory submissions
- Support the director of regulatory affairs in their absence
- Ability to provide technical input to review core documents
- Strong regulatory project management expertise, working across multiple projects to coordinate and manage submission activities
- Proven skills in working communicatively, with high attention to detail, and extremely well in a team
- Degree in life sciences – preferably Master or PhD but will also accept candidates with a bachelor’s degree
- Minimum 5 years’ experience in regulatory affairs
- Significant experience in Clinical Trial Authorisation (CTA) applications and maintenance submissions in Europe
- A strong knowledge of ATMP regulation and biological submissions
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading specialist life science 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.