Global Regulatory CMC Manager
Global Regulatory CMC Manager
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- 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.
- BS/BA degree in Scientific Discipline (masters or higher preferred) with.
- 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 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.
Employment Type
Full Time
