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    Principal Scientist- Global Regulatory Affairs-Cmcs

    Cpl
    3-7 years
    Not Disclosed
    Limerick
    12 June 10, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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

    Position: Principal Scientist - Global Regulatory Affairs-CMC

    Purpose:

    The Principal Scientist-Global Regulatory Affairs-CMC role aims to provide strategic, tactical, and operational direction to expedite CMC development and technical agendas by supporting global clinical trial, market registration submissions, and post-approval submissions. This is achieved through a strong understanding of global regulations, guidelines, and regulatory precedence, coupled with technical expertise in CMC development and manufacturing processes. The role also involves building productive relationships and influencing development, manufacturing, and regulatory leadership on key regulatory CMC positions.

    Responsibilities:

    • Oversee the preparation and documentation of specified regulatory submissions.
    • Provide regulatory leadership and direction for assigned products.
    • Develop, plan, and execute regulatory strategies and priorities in collaboration with other departments such as TS/MS, manufacturing, and quality control.
    • Manage submission timelines, monitor approval status, and communicate changes to relevant stakeholders.
    • Stay updated on existing and emerging pharmaceutical and biotech-related regulations.
    • Provide CM&C commitment information to site personnel.
    • Ensure compliance of GMP documents with regulatory commitments and support the batch release process.
    • Review and approve regulatory changes, deviations, reprocessing proposals, validation, and stability protocols.
    • Participate in Global Regulatory Affairs-CMC group activities to share best practices and develop internal guidelines/initiatives.
    • Attend industry association meetings and groups to benchmark and influence revisions to guidance documents.
    • Interpret new/revised guidance documents and evaluate their impact on the site, providing comments on draft guidance as applicable.
    • Provide training to site personnel regarding product registration requirements and applicable regulations and guidelines.

    Minimum Qualification Requirements:

    • Level 8 Bachelor's degree in sciences discipline (e.g., chemistry, biology, biochemistry, pharmacy, or related scientific discipline) required.
    • 3-7 years of prior Regulatory CMC experience or equivalent combination of technical and regulatory guidance knowledge and experience preparing regulatory submission content in a technical function.
    • 5-7 years of pharmaceutical industry experience in a CMC-related field will also be considered.

    Additional Skills/Preferences:

    • Strong knowledge of regulatory and compliance guidelines within pharmaceutical/biopharmaceutical manufacturing.
    • Attention to detail and effective teamwork skills.
    • Proven ability to influence within and beyond the organization.

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