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Regulatory Operations Senior Manager

Navitas Life Sciences
Navitas Life Sciences
10+ years
Not Disclosed
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.