Global Regulatory CMC Manager

Apply for the Global Regulatory CMC Manager role at Katalyst CRO

• Participate in the development of the CMC regulatory strategy for small molecules
• These submissions include health authority briefing packages, IND/CTA, 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

• Bachelor's Degree in life sciences or engineering, or other technical discipline.
• 3-5+ years in the pharmaceutical industry, preferably with 2+ years CMC regulatory experience.
• Experience with CMC regulatory documents (IND/CTAs, 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 the 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.

Mid-Senior level

Contract

Legal

Pharmaceutical Manufacturing

Location:

Detroit, MI