Global Regulatory CMC Manager

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. Requirements:

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).