Senior Manager (Level 1), Regulatory Affairs CMC

About the role

Participation in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations) including medical devices, cosmetics, food supplements and herbal products with emphasis on CMC aspects. Preparation, review and compilation of CMC documents within the framework of regulatory affairs projects.

What you'll do

• Develop and maintain strong client relationships and help drive opportunities for increased service support to Line Manager
• Support with scientific advice procedures and representation of clients with health authorities
• Present seminars and lectures for colleagues, clients and professional audiences. Active contribution and distribution of department relevant expertise
• Ensure personal leadership in supporting VDC strategy implementation and optimization
• Provide day to day operational support for colleagues

What you need

• 10–18 yrs of experience
• Regulatory affairs
• Cross-selling
• Communication
• B.Sc

Good to have

• Clinical research