Regulatory Affairs - Gene Therapy
A Clinical Stage Biotech is now recruiting for a Regulatory Affairs Manager with a full understanding of Gene Therapy. The organisation based in Hertfordshire are developing a Gene-therapy Treatment to better the lives of patient suffering from Chronic Systemic Diseases.
- Support global regulatory team and product development teams in all aspects of regulatory affairs, both strategic and operational.
- Support the Global Regulatory Companion Diagnostics, implement a successful co-development strategy that bridges across the assigned gene therapy(ies) and companion diagnostic(s).
- Ensuring preparation and submission of high-quality regulatory documents including, 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 contact point for internal and external clients, including CROs and regulatory authority interactions.
- Responsible for the regulatory project management for assigned projects
- Remain expert and up to date on global regulatory requirements including nonclinical and clinical aspects.
- Keep abreast of relevant regulatory intelligence and ensuring this is communicated, appropriately, across the Company.
- Assist with training of staff in regulatory matters as required.
Skills and Requirements
- Relevant degree in a life science / science discipline.
- At least 6-8 years' experience in regulatory affairs across various companies preferably in biotechnology/biologicals and/or rare diseases
- Gene Therapy is Essential.
- Knowledge and understanding of EU and ICH guidelines and experience of working to GxP is essential.
- Experience in the preparation of regulatory submissions during the lifecycle particularly INDs/CTAs, scientific advice briefing documents
In case you have difficulty in applying or if you have any questions, please contact Joe Dykes on 44 203 0789 542 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.