Offer summary
Qualifications:
Master degree or PhD in biotechnology, pharmaceutical sciences or bio-engineering, Min 10 years of relevant expertise in CMC development and regulatory for biological products, Strong knowledge of EMA regulations and ICH guidelines, Proven experience leading CMC regulatory submissions, Fluent in English.
Key responsabilities:
- Lead CMC regulatory strategies for biological products in EMEA
- Act as a subject matter expert on biologics and provide regulatory guidance
- Oversee preparation, review, and submission of CMC sections
- Coordinate responses to CMC-related inquiries from EMEA authorities
- Ensure management of post-approval changes and compliance throughout lifecycle