Director of Regulatory Affairs

3 days ago

Surrey, United Kingdom Blackfield Associates Full time

Our client, a continually expanding healthcare company is looking for a senior Regulatory director to join their team on an initial six-month assignment, to develop, lead and establish their regulatory strategy across lifecycle and new development assets.


As Senior Regulatory Director, you will:

  • Leading the development and implementation of innovative regulatory strategy, globally, whilst ensuring compliance with local and international regulations.
  • Building recommendations for the leadership team based on best practice, changing our current ways of working and advising the right systems to support business growth.
  • Partnering with the business as a strategic partner/advisor to help achieve company objectives including due diligence activities.
  • Overseeing and contributing to the preparation, submission, and management of regulatory documents (INDs, NDAs, MAAs, post approval variations etc.) to health authorities like the MHRA, FDA, EMA, and others.
  • Acting as the primary liaison with regulatory bodies, driving communications, and maximise the likelihood of timely approvals.
  • Enhance cross-functional communication with in house and external partners to assure alignment with regulatory strategy.
  • Lead and build the regulatory team to develop the knowledge, skills and capabilities to effectively deliver the business strategy. Build a culture of trust and communication so that the team can deliver to the best of their ability.
  • Maintain contemporary knowledge of global regulations and ensure effective knowledge sharing across the business.
  • Identifying potential regulatory risks and developing mitigation strategies


To be considered as the Senior Regulatory Director, you will:

  • Educated to Masters or similar level in a relevant scientific field such as Chemistry, biology, pharmacy or life sciences
  • Extensive, broad experience in global regulatory affairs within the pharmaceutical, biotech, medical device industry is essential – this role will suit a fast paced, dynamic individual with an entrepreneurial approach
  • Must have leadership experience of at least 4 direct reports, in a highly cross-functional business
  • Extensive knowledge and hands on of preparing and maintaining dossiers for clinical trials and marketing authorizations
  • Direct / proven experience working with / leading meetings with regulatory authorities including MHRA, EMA and exposure to FDA is highly desirable
  • Deep GxP knowledge is essential


This role is suitable for a hands on, fast-paced regulatory leader / doer. This is a role for a candidate to bring experience to maximise an opportunity for growth; a commercially astute professional. For more information, contact Rob Carnell at Blackfield Associates.

Due to the nature of business, candidates must be located within a reasonable commute and be present in the office on a hybrid/ 3 days per week basis. No Sponsorship/INSIDE IR35

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