Description
Senior Manager Regulatory Affairs - Amsterdam - 12 Month Contract
Optimus Search is currently in partnership with an international Biopharmaceutical company looking to recruit an experienced Senior Manager in Regulatory Affairs for their Benelux affiliate. The position will be based at their Amsterdam office.
Main Responsibilities:
- Reporting to the Associate Director Regulatory Affairs Benelux, you will be responsible for leading all regulatory activities in the NL.
- Working with cross-functional teams you will be an excellent communicator and will be responsible for ensuring all projects have the appropriate local regulatory input and guidance from the outset, a positive proactive mind-set is essential.
- You will be an expert in local regulatory affairs and quality systems and have previously worked extensively within the Pharmaceutical industry including experience of working with or in industry trade groups and regulatory affairs professional bodies.
- Experience in line management and an enthusiastic approach to people/team development is very important.
Key Skills and Qualifications:
- Typically requires a BA degree in a relevant discipline and minimum 5 years of relevant experience in Regulatory Affairs.
- An advanced degree is desirable. Management experience is required.
- Excellent verbal and written communication skills and interpersonal skills are required.
- Must have in-depth knowledge of regulatory requirements, including ICH requirements and regional requirements for assigned territories and have an in-depth understanding of current global and regional trends in Regulatory Affairs.
- Must be capable of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities.
- Must speak fluent French, Dutch and English.
If interested please respond with an updated C.V.