Senior Manager - International Regulatory Affairs - Germany

Responsibilities:

• Compile and maintain International regulatory dossiers
• Manage international regulatory procedure (MRP, DCP, CP)
• Represent Regulatory Affairs in RD project teams and advise Market Companies
• Asses in licensed dossiers (due diligence)
• Prepare investigational Medicinal Product Dossiers
• Work in close collaboration with regulatory authorities

Job Requirements:

Degree in Life Science or Pharmacy

Demonstrable understanding of CTD and e-CTD

Experience in drug development

Extensive knowledge  of international regulatory procedures and legal requirements 

Excellent command of English

Team spirit, well developed communication skills

Offert:

Performance based remuneration with comprehensive social security benefits, together with the advantages of working within a tight knit team that forms integral part of an international pharmaceutical group.

apastula@antal.com