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Head of Regulatory Affairs

2 months ago

Egham, United Kingdom Northreach Full time

Northreach is a recruitment agency that connects businesses with top talent in the cell & gene therapy, fintech, and digital sectors. Our mission is to provide clients and candidates with a seamless and personalised recruitment experience and create a positive work environment that encourages equality, innovation, and professional growth.

We have partnered with an international pharmaceutical company who are dedicated to maintaining access to niche medicines. They are leaders in acquiring, integrating and optimising medicines for small populations of patients.

They are looking for a new Head of Regulatory Affairs to join there fast growing dynamic team. You will be responsible for developing reg strategies across all phases of product development.


Key Activities / Key Responsibilities

  • Leading the development and implementation of innovative regulatory strategy, globally, whilst ensuring compliance with local and international regulations.
  • 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, 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. [VB1]
  • Maintain contemporary knowledge of global regulations and ensure effective knowledge sharing across the business.
  • Identifying potential regulatory risks and developing mitigation strategies.
  • Maintain contemporary knowledge of global regulations and ensure effective knowledge sharing across the business.
  • Identifying potential regulatory risks and developing mitigation strategies.


Experience

  • Extensive experience in global regulatory affairs within the pharmaceutical, biotech, medical device industry ideally within a dynamic, fast-moving environment.
  • Extensive knowledge of preparing and maintaining dossiers for clinical trials and marketing authorizations.
  • Experience of seeking advice from and leading meetings with regulatory agencies including the FDA, EMA, and others.
  • Experience of leading a growing team and partners across multiple countries and time zones.
  • Deep GxP knowledge.