Head of Regulatory Affairs - CRO - Germany

Posted 24 October 2022
Salary Competitive
LocationGermany
Job type Full Time
DisciplineCRO & Clinical Operations
Contact NameArchie McMillan

Job description

Mantell Associates is currently partnered with a global full-service CRO in their search for a Head of Regulatory Affairs.

Are you looking to join a globally renowned CRO?

Do you have experience with regulations within a clinical trail environment?

Are you looking to make a difference?

Our Global partner is currently expanding rapidly providing you with the great opportunity to develop and grow within an already established business. With a clear focus on employee progression, our partner organise monthly conversations where job progression is discussed leading to them having the one of lowest staff turnover rates within the industry.

Head of Regulatory Affairs - Responsibilities:

  • Providing regulatory and ethics authorities with clinical trial submission documentation, including export and import license applications.

  • Coordinating regulatory-related communication lines with ethics committees, vendors, regulatory authorities, and project teams.

  • Training project teams on regulatory requirements.

  • Greenlighting IP releases to sites following review of documents.

Head of Regulatory Affairs - Requirements:

  • Multiple years' experience working within the Regulatory Affairs space, with previous experience working on regulations within a clinical trial environment.

  • Communication with internal and external stakeholder experience.

  • MUST SPEAK FLUENT GERMAN

Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information, please contact Archie McMillan on +44 203 3854 7700 or archie.mcmillan@mantellassociates.com if you're looking to take a step up in your career.