Mary Bolt is recruiting for a Senior Regulatory Affairs Manager to join a multinational clinical-stage cell & gene therapy research company focused on the development and commercialisation of gene therapies for debilitating disorders based on a next-generation AAV gene therapy platform. This is a permanent role based in Hertfordshire (20 minutes North of London via train).
The organisation has a strong reputation for their technical and strategic expertise within the cell and gene therapy market across Europe and places a strong emphasis on innovation to make a difference to patients lives. Their gene therapy treatment builds upon their own pioneering work and their proprietary product which has already transformed the lives of patients by providing a safe, effective and reliable gene therapy.
Your main duties will be to:
- Participate in the development and implementation of regulatory strategy for specific programmes and may take the lead on the design and execution of certain regulatory activities/submissions necessary to support global product development and registration.
- 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 the 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.
Further responsibilities will include:
- Acting as a contact point for internal and external clients, including CROs and regulatory authority interactions.
- Keeping abreast of relevant regulatory intelligence and ensuring this is communicated, appropriately, across the Company.
- Providing regulatory input into technical change controls in a timely manner and assisting with training of staff in regulatory matters as required.
- Educated to degree level or above in life science or a related field with extensive experinece in Regulatory Affairs preferably in biotechnology/biologicals and/or rare diseases including experience of European and US environments from early development, through CTA/IND to MAA/BLA filings and post-approval maintenance.
- Knowledge and understanding of US, EU, Canada, and ICH guidelines and experience of planning and leading meetings with the FDA, the EMA and European national regulatory authorities.
- Excellent communication and influencing skills and the ability to work effectively and collaboratively in a matrix environment across different personalities/cultures and functions as well as under pressure.
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 CL44398 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group
- Contact: Mary Bolt
- Phone: 01438 743047
- Reference: CL44398
- Posted: 11th January 2019
- Expires: 8th February 2019