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    Regulatory Operations Senior Manager

    Navitas Life Sciences
    10+ years
    Not Disclosed
    Princeton Junction
    10 July 26, 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

    Job Description: Senior Manager of Regulatory Operations

    We are seeking a Senior Manager of Regulatory Operations to lead and innovate within our regulatory affairs team. This role is pivotal in shaping and executing regulatory strategies for novel drugs, managing day-to-day operations, and ensuring compliance with global regulatory standards.

    Core Responsibilities:

    • Regulatory Strategy Development:

      • Strategic Planning: Develop and implement novel drug regulatory strategies.
      • Regulatory Advice: Provide sound regulatory advice on key development issues and communicate strategies to stakeholders.

    • Operational Management:

      • Project Management: Oversee daily operations using project management tools, creating and maintaining detailed project timelines.
      • Compliance: Ensure development programs comply with ICH and local regulatory requirements.

    • Documentation and Compliance:

      • SOPs and Workflows: Initiate, author, and collaborate on SOPs, work instructions, and workflows for regulatory operations (e.g., eCTD submissions, Investigational and Marketing Applications).
      • Document Authoring: Author clear and concise regulatory documents (CMC authoring) with oversight for regulatory submissions and messaging.

    • Strategic Alignment:

      • Development Coordination: Collaborate with development teams to align regulatory strategy, CMC strategy, and labeling strategy for Pharmaceutical/Biological products.
      • Regulatory Liaison: Serve as the primary point of contact between the company and regulatory agencies.

    • EU Expansion Strategy:

      • MAA Planning: Strategize and plan for EU expansion, including MAA submissions (DCP, CP, NP, MRP), and setting up EU QPPV Office.

    Desirable Skills and Experience:

    • Experience: 10–15 years in a regulated life science environment with a focus on regulatory operations.
    • Project Management: Strong skills in project management, planning, and execution.
    • Interpersonal Skills: Excellent communication and interpersonal skills.
    • Business Development: Experience in organizational strategy, process management, KPIs, metrics, and resource forecasting.
    • Regulatory Knowledge: Extensive knowledge of global submission standards (FDA, HC, EMA, ICH, eCTD), regulatory change management, and operations.
    • Market Knowledge: Familiarity with RoW markets is a plus; experience in medical device regulations is advantageous.
    • eCTD Systems: Knowledge of eCTD publishing systems, TRS toolbox, and related tools.
    • Regulatory Information Management: Strong understanding of regulatory information management concepts and tools for prioritizing regulatory operations.

    This role is designed for a strategic leader with substantial experience in regulatory affairs, project management, and compliance, capable of driving regulatory strategy and operations across global markets.

     

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