Director Drug Regulatory Affairs
The Director Drug Regulatory Affairs will Lead SurgVision’s worldwide regulatory submissions for the Drug specific product lines used in combination with the explorer medical devices as an integrated solution. Align with Program Management functions to support new product development, product launch, product life cycle management and corporate objectives.
• 10+ years medical/drug industry experience.
• Track record in Regulatory Affairs with strong drug submission experienced in the global drug arena.
• Experienced working in (virtual and matrix) teams within a drug regulatory function.
• Experience with quality systems regulations and guidelines, ISO, Etc .
• Knowledge of global adverse event reporting requirements.
• Experienced in submitting biological products, especially antibodies.
• Fluent in English, additional languages are an asset.
If you are interested in this position and would like to know more about it, please contact:
Thema Group Search & Selection
Peter Kremer, Senior Recruitment Consultant / Partner
Tel: +31 6 51 84 61 62
Tagcloud Director Drug Regulatory Affairs
CQM- Pharma- Farma- Pharmaceutical- Qality Management Systems