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New Brunswick

    CMC Senior Manager - New Brunswick, United States - Sunrise Systems Inc

    Sunrise Systems Inc background
    Description

    PREREQUISITES

    BS/BA degree in Scientific Discipline (master's or higher preferred) with 5+ years in the pharmaceutical industry, preferably with 3+ years CMC regulatory experience

    Skills/Knowledge Required:

    • 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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