Global Regulatory CMC Manager
3551 Lawrenceville Road Trenton, NJ 08648 US
Target Pay Rate: 60-87.07/hr **salary will be commensurate with experience
PREREQUISITES BS/BA degree in Scientific Discipline (Master's or higher preferred) with 3-5+ years in the pharmaceutical industry, preferably with 2+ years CMC regulatory experience
Responsibilities will include, but are not limited to, the following:
- 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.
- 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 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
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