Offer summary
Qualifications:
University-level education in Life Sciences or equivalent experience, Extensive regulatory affairs experience in pharmaceuticals, Strong understanding of CMC and post-approval requirements, Experience writing technical sections of regulatory documents, Fluent in English (written and spoken).
Key responsabilities:
- Lead projects and ensure successful planning
- Maintain client communication and project reporting
- Develop and implement submission strategies for CMC
- Review study reports for regulatory compliance
- Mentor junior team members and deliver presentations