Senior manager / Associate Director - Regulatory Affairs CMC

A biotech moving to a Phase II/III with strong result on their product in development is looking to strengthen his CMC teams. With 20 people working in the company, you will be joining a Biotech where you will have the opportunity to know everyone and build strong connection. They are working on Biologics product (mAb)

Also, as you will be working cross-functionally with other teams, this will give you the opportunity to be close to the decision maker. This means a capacity to move quicker and avoid all the decision-making process you can have.

Depending on your experience, your involvement in the strategy will be impacted. You will have a room of growth there.

Your tasks:

• Define, participate, and challenge the CMC regulatory strategy.
• Preparation and submission of the CMC files for the MAA/BLA submission.
• Prepare and interact with the health authorities (EMA, FDA) to respond to their questions.

Votre experience:

• You have a strong scientific background: Pharm D, PhD…
• At least 5 years of experience in the Pharmaceutical, Biotechnology industry on similar role
• You have been working with Biologics product in development: IMPD/IND…

You can contact me via Linkedin or Email: brieuc@warmanobrien.com for a confidential conversation.