Job Description

• 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).

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