Project Manager (C9885)
Responsibilities will include, but are not limited to, the following:
1. Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions. These submissions include health authority briefing packages, IND/CTA, BLA/NDA and MAA regulatory filings.
2. 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.
3. Responsible for the global regulatory evaluation of CMC change controls with supervision.
4. Responsible for the management of CMC activities related to developmental or commercial compounds, with supervision.
5. Represent Regulatory CMC on cross-functional development/commercial teams and Regulatory Affairs teams.
6. Participate in global regulatory interactions with health authorities, with supervision.
7. Facilitate document review meetings and discussions.
8. Develop and maintain knowledge of regulatory environment, regulations and procedures.
Experience with CMC regulatory documents (IND/CTAs, BLA/NDAs, MAAs, responses, variations and briefing documents)
Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations
Experience in drug development processes and post-approval requirements
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