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Head of Regulatory Affairs

Great Maze Pond, Central London   •  £95000 - £125000 per annum  •  Permanent, Full time

Chloe Merrill is recruiting for a Head of Regulatory Affairs to join a leading advanced therapy research organisation.

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

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

Salary of £95,000 ? £125,000 plus package.

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
  • Posted: 1st June 2022
  • Expires: 29th June 2022

CK Group

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