Offer summary
Qualifications:
9+ years of industry experience in CMC regulatory function, Degree in Science (Biology, Biochemistry, Chemistry, Bioengineering, etc.), Proficiency in regulatory submission processes, Previous regulatory experience in biologics development preferrred, Knowledge of FDA and USDA regulations.
Key responsabilities:
- Lead the preparation of CMC regulatory submissions
- Develop CMC global regulatory strategies
- Collaborate with cross-functional teams for compliance
- Engage with regulatory agencies for CMC topics
- Conduct assessments of changes in production quality