Head of Regulatory Affairs

As a Head of Regulatory Affairs, you will be driving the Regulatory Strategy for the product in development. Having a pipeline with 3 molecules in Phase I & II you will define the strategy moving forward up to the product registration.
Working closely to the members of the board, you will have all the insight to take the lead for the Regulatory Activities within the Biotech.
 

Your tasks:

• Develop, and implement the regulatory strategy for the products in development.
• Lead the meeting with the health authorities (EMA, FDA)
• Prepare, review, and deliver the documents submissions
• Coordinate the activities with the partners: CRO, CDMO, CMO and consultant.

Your experience:

• You have a scientific background with at least 15 years of experience in Pharmaceutical OR Biotechnology companies.
• You have led the development of product in the past, ideally manage to register products on the markets
• Strong communication skills.
• Speaking English, French being a plus.

Contact :

Contact me via Linkedin or via email: brieuc@warmanobrien.com to organise a confidential conversation.