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| Job Location | London |
| Education | Not Mentioned |
| Salary | £60,000 - £65,000 per annum |
| Industry | Not Mentioned |
| Functional Area | Not Mentioned |
| Job Type | Permanent, full-time |
Senior Regulatory Affairs ManagerLondon£60,000 - £65,000Our client is looking for a Senior Regulatory Affairs Manager to join their ever-growing company on a permanent basis to create and implement optimal regulatory strategies for each programme in agreement with the Head of Regulatory Affairs.The successful Senior Regulatory Affairs Manager will be responsible for supporting the development programmes in place across the company, providing expert advice to ensure the programmes are developed in a way which meet regulatory and quality requirements.Key Responsibilities as a Senior Regulatory Affairs Manager :* To liaise closely with relevant departments 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 activitiesPlease apply as directed.