Chloe Merrill is recruiting for a Head of Regulatory Affairs to join a leading advanced therapy research organisation.
Responsibilities:
The Head of Regulatory Affairs will lead environmental shaping activities and take overall regulatory responsibility for every programme sponsored by the company.
Key duties will include:
- Maintain up to date knowledge of development in regulations, CMC and GMP requirements for ATMPs.
- Develop and maintain constructive working relationships with Health Authority contacts and industry groups, actively developing and leading strategies to influence regulators as required towards appropriate risk evaluation and management
- With the CCO, and Director of Access Strategy, develop an agreed regulatory strategy and implementation plan for each programme
- Ensure regulatory strategies achieve the agreed objectives and standards, minimise resource demands whilst maximising overall project delivery time and probability of success and facilitating post filing activities
- Actively participate in seeking out new collaborations and ensure the resourcing matches the workload and the financial and impact targets
- Ensure appropriate regulatory due diligence is carried out on all incoming collaborative projects
- Lead the preparation of regulatory contributions (briefing documents, CTAs, INDs, amendments, safety reports, annual reports, etc.) to meet business needs and agreed time, cost and quality standards
Qualifications:
As Head of Regulatory Affairs you will require:
- Extensive experience in appropriate regulatory role, including previous leadership roles
- Excellent written and verbal communication skills
- Budget & Financial acumen
- Ambitious, collaborative, driven
- Desire to establish a high profile career within cell and gene sector
- Flexible and pragmatic, able to learn quickly and respond flexibly to project needs and priorities
- Resilience, with the ability to work well under pressure, to work independently and to be able to take the initiative when completing tasks and work both reactively and pro-actively
Benefits:
Salary of £95,000 ? £125,000 plus package.
Apply:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 53790 in all correspondence.
You must have the right to work in the UK. Learn more
- Agency: CK Group
- Reference: 53790
Website: CK Group
- Posted: 1st June 2022
- Expires: 29th June 2022
