Offer summary
Qualifications:
Master degree or PhD in biotechnology, pharmaceutical sciences, or bio-engineering., Minimum 10 years of relevant expertise in CMC development and regulatory for biological products., Strong knowledge of EMA regulations and ICH guidelines..
Key responsabilities:
- Lead development and execution of CMC regulatory strategies for biological products in EMEA.
- Serve as a subject matter expert on biologics and provide regulatory guidance.
- Oversee preparation and submission of CMC sections specific to biological products.
- Manage post-approval compliance and lifecycle changes for biological products.
- Monitor regulatory guidance related to biologics and provide strategic input.