Head of Regulatory Affairs

1 week ago


المملكة العربية السعودية, Saudi Arabia Mantell Associates Full time

Job description:


Mantell Associates is currently partnered with a leading Biopharmaceutical organisation in their search for a Head of Regulatory Affairs to join their growing team.


Head of Regulatory Affairs - Responsibilities:

  • Develop and implement regulatory strategies, ensuring compliance with local regulations and guidelines
  • Lead and manage regulatory submissions for clinical trials and product approvals, including interactions with regulatory agencies, consultants, and partners
  • Build and maintain relationships with regulatory authorities, key opinion leaders, and industry associations
  • Provide strategic advice to crossfunctional teams on regulatory requirements and timelines for product development and commercialisation
  • Ensure the company's quality system is in compliance with regulatory requirements, and lead regulatory inspections
  • Stay uptodate with regulatory developments and trends in the biotech industry and provide guidance to the company on emerging regulatory issues
  • Manage and develop the regulatory affairs team, including recruitment, training, and performance management
**Head of Regulatory Affairs

  • Requirements**:
  • Advanced degree in a scientific or related field, with strong regulatory affairs experience in the biotech or pharmaceutical industry
  • Extensive knowledge of regulatory requirements for drug development and product approvals
  • Proven track record in successful interactions with regulatory authorities and successful regulatory submissions
  • Strong leadership and people management skills, with experience leading and developing regulatory affairs teams
  • Excellent communication and interpersonal skills, with the ability to interact effectively with internal and external stakeholders
  • Strong analytical and problemsolving skills, with the ability to manage multiple priorities in a fastpaced environment
Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at

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Siobhan McLoughlin:

  • Siobhan


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