Senior Regulatory Affairs Manager
A popular hospital in search of an experienced Regulatory Affairs Manager to provide operational support. The London based role will focus on clinical trials and manufacturing initiatives.
- To liaise closely with relevant departments across CGT Catapult and external Collaborators to ensure proposed developments (manufacturing and analytical) are fit for purpose and suitably planned whilst ensuring the development programme will meet regulatory and quality requirements
- With the Head of Regulatory Affairs, develop an agreed regulatory strategy and implementation plan for each programme
- Maintain up to date knowledge of development in regulations, CMC and GMP requirements for ATMPs
- Author and compile regulatory documents (briefing documents, CTAs, INDs, amendments, safety reports, annual reports, etc.) to meet business needs and agreed time, cost and quality standards
- Ensure appropriate regulatory due diligence is carried out on all incoming propositions and external facing proposals
- Develop and maintain constructive working relationships with Competent Authority and Health Authority contacts, contributing to strategies to influence regulators as required towards appropriate risk evaluation and management
- Line management of more junior members of the team including delegation of key activities
Skills and Experience:
- Graduate in a life science subject as a minimum, post graduate degree desirable
- Minimum 5+ years' proven experience in an appropriate regulatory role, with experience in Advanced Therapy Medicinal Products preferred
- Experience in implementing and helping to develop regulatory strategies for Advanced Therapy Medicinal Products including orphan indications
- Keeps up to date with professional knowledge, expertise and best practice.
- Excellent oral and written communication skills.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical and medical device companies.