- Responsible for preparation of high quality regulatory submission content focusing on chemistry, manufacturing, and control (CMC) to support global clinical development, registration, and product life cycle management
- Prepare regulatory submissions that involve CMC components including pipeline programs (IMPD/CTA/IND), Marketing Applications (NDA, MAA, JNDA) and Agency request for information, Briefing Books, Post- Approval changes or compliance updates.
- Work cooperatively with colleagues in applicable expertise areas (Process Development, Analytical Development, Manufacturing, Supply Chain, Validation, Quality Control and Quality Assurance) and external organizations (e.g., CMO) to ensure achievement of Alnylam’s objectives relating to the preparation of CMC regulatory submissions and associated activities
- Actively participate in RA CMC infrastructure and capability building. Assists in the development and implementations of departmental processes, procedures and policies