Head of Regulatory Affairs - Biotech

Posted 03 April 2023
Salary Competitive
Job type Full Time
DisciplineCRO & Clinical Operations
Contact NameGeorge Hebden Lee

Job description

Key Responsibilities:

  • Develop and implement regulatory strategies for our products in Germany and other markets, 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 commercialization.

  • 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 in Germany, including recruitment, training, and performance management.


  • Advanced degree in a scientific or related field, with a minimum of 10 years of regulatory affairs experience in the biotech or pharmaceutical industry.

  • Extensive knowledge of regulatory requirements for drug development and product approvals in Germany and the EU.

  • 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.

  • Fluent in German and English, with excellent written and verbal communication skills in both languages.

  • Experience in rare diseases and/or orphan drug development is a plus.

Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact George Hebden Lee at +44 (0)20 3854 7700 or George.hebden-lee@mantellassociates.com.