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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.

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

CK Group

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