Regulatory Affairs Senior Manager - EU
|Area||Central London, UK|
|Sector||Pharma / Biotech|
|Salary||£ 65,000 ~ 75,000 Annual Rate|
A cutting-edge biotech working on products to treat cancer using cellular immunotherapy. With three products in phase I and II and a further five products in pre-clinical stages, they looking for a Regulatory Affairs Senior Manager with strong drug development experience.
- Prepare and submit clinical trial applications, substantial amendments, regulatory responses, orphan drug designation requests and maintenance, PIPs, and MAAs to meet company goals and timelines. Must be able to write significant sections of regulatory submissions with input from internal teams and consultants.
- Schedule, prepare meeting packages for, and coordinate scientific advice meetings with regulatory authorities.
- Represent regulatory affairs function within cross-functional product development teams.
- Act as a company expert in EU Regulatory Affairs, providing updates, support and education as required.
- Act as primary contact to EU regulatory authorities.
- Review all regulatory agency compliance materials to guarantee accuracy, timeliness, comprehensiveness, and adherence to regulatory standards.
- Maintain current knowledge of relevant EU regulations including proposed and final rules and communicate changes to internal team.
- Liaise with external collaborators and manage external resources e.g. CROs, consultants
- Contribute to the global regulatory function and organisation of company regulatory data (SOPs, trackers, templates, etc).
- Play an instrumental role in the global regulatory affairs function through active participation and collaboration
- Involved with development of regulatory strategies for new products.
- Provide regulatory input on other company activities such as pharmacovigilance, medical affairs, risk management, company brochures, and due diligence.
For further information please contact Natalie Hopkins on 0207 183 5059 or email firstname.lastname@example.org