CK Clinical are recruiting for a Senior Regulatory Affairs Manager to join a world leading research company in London on a permanent basis.
Senior Regulatory Affairs Manager Role:
The main purpose of the role will be to:
- Devise and implement optimal regulatory strategies for each programme in agreement with the Head of Regulatory Affairs.
- Support the development programmes in place, providing expert advice to ensure the programmes are developed in a way which meet regulatory and quality requirements.
- 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.
- Ensuring appropriate regulatory due diligence is carried out on all incoming propositions and external facing proposals.
- Developing and maintaining constructive working relationships with Competent Authority and Health Authority contacts and 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.
- Education to degree level or above in life science or a related field with significant experience of working within Regulatory Affairs to a Senior level and ideally in the ATMP/cell and gene therapy field.
- Experience in implementing and helping to develop regulatory strategies (ideally for ATMP products) including orphan indications, managing complex regulatory issues and leading the regulatory aspects of the development strategy.
- Proven ability to engage constructively with colleagues at all levels across different departments to deliver objectives as well as demonstrable regulatory leadership of IND and CTA processes and experience of scientific advice meetings with Regulatory Authorities.
For more information or to apply for this Senior Regulatory Affairs Manager position, please contact CK Group, quoting job ref 48762.
It is essential that applicants hold entitlement to work in the UK.