Interact with national and sovra-national agencies
You will lead all aspects of Regulatory Affairs CMC of Investigational Medicinal Products in clinical development
Job Summary
You will lead all aspects of Regulatory Affairs CMC of Investigational Medicinal Products in clinical development.
As you guide the products along this exciting path, you will establish new regulatory paths and define requirements for these next generation of therapeutics.
BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base.
Matching Summary
You will lead all aspects of Regulatory Affairs CMC of Investigational Medicinal Products in clinical development.
Skills & Requirements
Must-have
Global Regulatory Affairs CMC lead
Define and execute Global Regulatory CMC strategy
Interact with national and sovra-national agencies
Prepare and review regulatory CMC submission packages
Implement and optimize regulatory CMC processes
Monitor regulatory CMC landscape evolution
Nice-to-have
Result- and goal-oriented
Excellent communication skills
Key Requirements
Degree in pharmacy, chemistry, biology, biochemistry, or equivalent
More than 9 years professional working experience in Regulatory Affairs CMC
Extensive experience in preparation and revision of regulatory CMC documents