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    Senior Manager I, Grs-Cmc Small Molecules

    Bristol Myers Squibb
    3-5 years
    preferred by company
    Hyderabad
    10 Nov. 22, 2024
    Job Description
    Job Type: Full Time Education: BA/BS Degree Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Description

    Position: Senior Manager I – Global Regulatory Sciences – CMC (EG-120)
    Location: Hyderabad

    Working with Us

    At Bristol Myers Squibb, we offer a unique and meaningful work environment where every day presents an opportunity to transform lives—our patients’ and our employees’. Whether optimizing production or advancing breakthroughs in cell therapy, your work here will make a life-changing impact.

    We provide an inclusive and diverse workplace, offering opportunities for growth, flexibility, and balance. Discover more about how we support your career and personal aspirations: careers.bms.com/working-with-us.

    Functional Area

    Global Regulatory Sciences – Chemistry, Manufacturing, and Controls (GRS-CMC):
    GRS-CMC provides expertise throughout a product’s lifecycle, including:

    • Developing global regulatory CMC strategies aligned with business priorities.
    • Supporting regulatory submissions and health authority interactions.
    • Offering regulatory guidance for manufacturing changes and medical devices.
    • Supporting Medical Information by building/maintaining databases to address external inquiries.

    Position Summary

    The Senior Manager I – GRS-CMC will lead and oversee the development, maintenance, and review of regulatory submissions' Quality Modules for clinical trial applications, marketing authorizations, and post-approval changes. The role includes interfacing with Global Regulatory Sciences (GRS) and Global Product Supply (GPS), assessing manufacturing change controls for global impact, and providing guidance on regulatory change management.

    Key Responsibilities

    Regulatory Strategy and Expertise

    • Provide strategic CMC regulatory guidance for development and commercial teams.
    • Interpret global regulations and guidelines, identifying risks and proposing mitigation strategies.
    • Support project matrix teams for lifecycle management, including pediatric formulations and line extensions.
    • Serve as a key interface with health authorities, including the US FDA, for CMC submissions and queries.

    Documentation and Compliance

    • Develop, compile, and maintain the Quality Modules of regulatory submissions for:
      • Clinical trial applications.
      • New marketing applications.
      • Health authority responses and post-approval submissions.
    • Ensure accuracy, thoroughness, and timeliness in submissions and technical documentation.

    Collaboration and Communication

    • Work closely with technical teams to address regulatory expectations and provide insights into health authority requirements.
    • Communicate with project teams to resolve technical and regulatory issues that may impact submission success.
    • Provide regular updates to team leaders on progress and challenges.

    Qualifications & Experience

    • Education: Minimum BA/BS degree required.
    • Experience:
      • 3–5+ years in the pharmaceutical industry or related field.
      • At least 2+ years in CMC regulatory or relevant experience.
    • Skills & Knowledge:
      • Deep understanding of global CMC regulatory requirements for small molecules and biologics (development and post-approval).
      • Strong ability to manage multiple projects, prioritize tasks, and work independently or as part of a team.
      • Proficiency in interpreting regulations, resolving complex issues, and preparing thorough regulatory filings.
      • Excellent oral and written communication skills.
      • Familiarity with electronic systems.

    If you’re excited about a role that may not perfectly align with your resume, we encourage you to apply. You could be one step away from work that transforms your life and career.

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