What are the responsibilities and job description for the Global Regulatory CMC Manager position at Katalyst CRO?
Responsibilities
- Prepare and review CMC submission documents, registration dossiers, health authority briefing packages and responses to health authorities through collaborations with relevant line functions and with minimal supervision.
- Responsible for the global regulatory evaluation of CMC change controls with supervision.
- Responsible for the management of CMC activities related to developmental or commercial compounds, with supervision.
- Represent Regulatory CMC on cross-functional development/commercial teams and Regulatory Affairs teams.
- Facilitate document review meetings and discussions.
- Develop and maintain knowledge of regulatory environment, regulations and procedures.
- Participate in the development of the CMC regulatory strategy for biologics submissions. These submissions include health authority briefing packages, IND/CTA, BLA/NDA and MAA regulatory filings.
- Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations.
- Experience in drug development processes and post-approval requirement.
- Experience in developing CMC regulatory strategy.
- Experience in project management.
- Have a solution-oriented approach to problem solving.
- Ability to plan/prioritize work of group members and guide/develop others.
- Ability to work on complex projects and within cross-functional teams with supervision.
- Excellent communication skills, both written and oral.
- Experience with CMC regulatory documents (IND/CTAs, BLAs, MAAs, responses and variations).
