Global Regulatory CMC Manager
Posted on :
16-11-2022
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Job Description
Responsibilities:
- Education : 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
- Participate in the development of the CMC regulatory strategy for post-approval small molecule product submissions, including global supplements/variations and responses to health authority queries.
- Prepare and review CMC submission documents, registration dossiers, and responses to health authorities through collaborations with relevant line functions and with minimal supervision.
- May be responsible for the global regulatory evaluation of CMC change controls with supervision.
- Work with CMC cross-functional teams and Regulatory Affairs teams.
- Develop and maintain know
- Experience with CMC regulatory documents (global registrations, including NDAs, MAAs and others, responses and supplements/variations)
- Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations
- Experience in 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
- Excellent computer skills ledge of regulatory environment, regulations, and procedures.
Employment Type
Full Time
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