Responsibilities :
- PREREQUISITES BS / BA degree in Scientific Discipline (master's or higher preferred) with + years in the pharmaceutical industry, preferably with + years CMC regulatory experience, Sterile Injectable experience preferred.
- 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 knowledge of regulatory environment, regulations, and procedures.
Requirements :
- 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.
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