Regulatory Affairs Manager
Leading Cell and Gene Therapy company
Home based in the UK
Maximum salary of £58,000 per annum with benefits
The Key Purpose of the role is to:
- Implement optimal regulatory strategies for each programme
- Compile and submit regulatory submissions
- To support the development programmes in place
- Develop an agreed regulatory strategy and implementation plan for each programme
- Prepare regulatory documents (briefing documents, GMO submissions, CTAs, INDs, amendments, safety reports, annual reports, etc.
- Develop and maintain constructive working relationships with regulatory agency and health authority contacts.
- Approximately 3-5 years' or more regulatory affairs experience, ideally with 1-2 years in a cell and/or gene therapy environment or, at a minimum, with some experience in the regulation of biologic or biotech products
- Proven experience of working independently in the drafting and delivery of high quality regulatory documents
Knowledge / Skills / Competencies:
- Proven ability to evaluate and implement efficient regulatory strategies
- Ability to lead the quality and regulatory aspects of the development strategy for assigned Programmes
- Demonstrable regulatory leadership of CTA /IND processes as well as experience of scientific advice meetings with Regulatory Authorities is an advantage
In addition, one or a combination of the following are also highly desirable
- Experience of registration of cell and gene therapies for clinical trial throughout the EU/UK and US
- Experience of EU centralised procedures such as ATMP classification, paediatric investigational plans and orphan drug applications
- Knowledge of US, Japanese, Canadian or Chinese regulatory frameworks
- Working knowledge of EU GMP and tissues and cells legislation
Education / Qualifications:
- Higher degree or at a minimum graduate in a life science subject.