CMC Manager

CMC MANAGER SUMMIT, NJ Required Skills:

• BS/BA degree in Scientific Discipline (Masters or higher preferred) with 5-7 years in the pharmaceutical industry, preferably with 1-3 years CMC regulatory experience .
• 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 .
• Change control (be able to work in CC systems i.e., eQRMS, Infinity, Verity) .

• 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.
• 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.
• Participate in global regulatory interactions with health authorities, with supervision.
• Facilitate document review meetings and discussions.
• Develop and maintain knowledge of regulatory environment, regulations, and procedures.