Regulatory Affairs Manager (CMC)

What we expect

• BS in biological, pharmaceutical, chemical or engineering sciences with generally a minimum of 8+ years of experience inclusive of post graduate education and/or pharmaceutical or health care industry experience or equivalent. 
• proficiency in English (min. C1).
• demonstrated ability to communicate regulatory requirements.
• solid understanding of biology, chemistry and/or engineering relevant to pharmaceutical industry 
• experience developing regulatory strategies and an understanding of product development, seen as an expert on product development and how it is applied in global regulatory strategy.
• strong attention to detail with high-level verbal and written communication skills 
• communicates cross-functionally and cross-company. Presents and defends CMC management-approved regulatory strategy and opinion to project teams.
• demonstrates model behavior that understands what the priorities are and encourages others to drive for results
• experience interacting with Health Authorities under supervision of a senior member of the CMC RA staff. 
• good knowledge of global HA laws, regulations, guidance and regulation submission routes available for assigned products.
• some understanding of competitors in the area and what they are doing in early/late development 

Employment agency entry number 47

this job offer is intended for people over 18 years of age

Employment agency entry number 47

this job offer is intended for people over 18 years of age