Head of Regulatory Affairs - CRO

Head of Regulatory Affairs – Regional for Germany

Office based Munich – 2 days WFH a week

Salary - €80-100k basic plus benefits

Our client a leading provider of clinical trials is looking for a Head of Regulatory Affairs.

This role will be responsible for a team of 8 reporting directly to the Director of Regulatory affairs. You will focus on facilitating the start of research projects of medicinal products, while leading the regulatory team. With your team management experience and your excellent knowledge of German regulatory procedures including submissions, regulatory proposals and bid defense you will be joining an established international organization with a true focus on its people You will be given ownership of your projects with necessary support provided to lead your team effectively.

Typical responsibilities will include

Your role:

• Management of Regulatory Affairs team in Germany (setting operational objectives and team goals)
• Prepare and review clinical trial submission dossiers for Regulatory and Ethics Authorities
• Communicate with regulatory authorities, ethics committees, project teams and vendors on regulatory-related matters
• System audits and facilitate regulatory inspections
• Develop and implement training programs, quality systems, controls and documents at the local level
• Manage the procurement of study-specific documents and translations
• Oversee and manage safety reporting to authorities
• Advise and guide on feasibility research and business development requests
• Participate in internal or client bid-defense or kick-off meetings, as required

Qualifications

• Educated to degree level (Life Sciences is a plus) or equivalent
• A minimum of 5 years’ experience in clinical trial submissions in Germany
• A minimum of 2 years of people line management experience
• Excellent knowledge of Clinical trial regulations in Germany
• Previous involvement in the development of regulatory aspects of proposals and participation in bid defenses
• Excellent communication skills.
• Fluency in English and German

For further information please contact Louise directly on +44 (0)1293 364114