Offer summary
Qualifications:
8-10 years experience in biotech/pharmaceutical industry, Bachelor’s degree in related field, Strong knowledge of regulations (ICH, FDA, EMA), Excellent written and verbal communication skills, Science-based reasoning skills.
Key responsabilities:
- Manage global submissions and vendors
- Ensure compliance and quality of regulatory documents
- Author SOPs, work instructions, workflows for regulatory function
- Participate in global health agency interactions
- Contribute to an innovative and inclusive culture