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.