Head of Regulatory Affairs - Biopharmaceutical

Posted 31 July 2023
Salary Negotiable
LocationAsia
Job type Full Time
Discipline Small Molecule
ReferenceBBBH1240_1690813354
Contact NameThomas White

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 cross-functional 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 up-to-date 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 problem-solving skills, with the ability to manage multiple priorities in a fast-paced environment

Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +44 (0)20 3854 7700.