Senior Manager Regulatory Affairs
CK Group are recruiting for a Senior Regulatory Affairs Manager to join a multinational clinical-stage research company focused on the development and commercialisation of gene therapies for debilitating disorders based on a next-generation AAV gene therapy platform. This will be at their site based in Stevenage on a permanent basis.
The organisation has a strong reputation for their technical and strategic expertise within the cell and gene therapy market across Europe. They place a strong emphasis on innovation, the ability to make a difference to patients lives and enabling staff to apply their skills whilst developing by collaborating within a multidisciplinary team. They will provide you with promising and exciting research projects in an environment that strongly values your development. Their gene therapy treatment builds upon their own pioneering work and their proprietary AAV capsid which is optimised to effectively transduce human liver cells and thus provide sustainable, high levels of the desired protein.
This role is located in Stevenage, Hertfordshire. The site is easily commutable by both train and road having strong rail networks with London and being reachable from the M1, M25 and A1(M).
Your main duties will be to:
- Support the regulatory sub-team and product development teams in all aspects of regulatory affairs, both strategic and operational, and provide input into relevant sections of development plans for assigned programmes.
- Ensure preparation of high-quality regulatory documents 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.
- Act as a contact point for internal and external clients, including CROs and regulatory authority interactions and contribute to the growth of the Function, including supporting GxP compliance and inspections and regulatory systems.
- Keep up to dare with relevant regulatory intelligence and ensure that this is communicated appropriately across the company.
The ideal candidate for this role will have:
- Been educated to degree level or above in life sciences or a related field with significant experience within regulatory affairs in the biotech industry.
- Experience of European and US environments from early development, through CTA/IND to MAA/BLA filings and post-approval maintenance.
- Experience of planning and leading meetings with the FDA, the EMA and European national regulatory authorities.
- Demonstrated ability to create and drive an effective regulatory strategy and handle critical issues effectively with demonstrated creativity in solving regulatory issues.
For more information or to apply for this position, please contact Mary Bolt on 01246 457729 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 47668 in all correspondence.