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    Director, Regulatory Affairs Cmc

    Gsk Plc
    10+ years
    Not Disclosed
    Collegeville
    10 Jan. 21, 2025
    Job Description
    Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates 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 Title: Director, Regulatory Affairs CMC

    Location Options:

    • London, United Kingdom
    • Baar, Switzerland
    • Rixensart, Belgium
    • Stevenage, United Kingdom
    • Collegeville, Pennsylvania, USA

    Category: Regulatory
    Posted Date: November 19, 2024

    Company Overview

    GSK is a global biopharmaceutical company with a purpose: to unite science, technology, and talent to get ahead of disease together. We focus on vaccines, specialty medicines, and general medicines, with emphasis on infectious diseases, HIV, respiratory/immunology, and oncology. We are committed to advancing medical discovery and positively impacting the health of billions of people worldwide. At GSK, we foster a culture where people thrive, grow, and contribute meaningfully to our mission.

    Role Overview

    The Director of Regulatory Affairs CMC will lead strategic CMC regulatory activities for investigational and early commercial biological products. This role is critical in providing regulatory leadership to CMC development teams and the Pharma Supply Chain organization, ensuring the approval and continuous supply of medicines to patients. The Director will work on global regulatory strategies, authoring and preparing CMC regulatory documents, and guiding the business on key strategic initiatives across multiple biopharmaceutical modalities.

    Key Responsibilities

    1. Leadership of CMC Regulatory Activities

      • Lead CMC regulatory activities for investigational, late development, and early commercial GSK products.
      • Develop and drive the CMC regulatory strategy, coordinating the preparation of technical documents for development, registration, and life cycle maintenance submissions.
      • Identify risks to the business related to submission data and information, providing risk mitigation strategies.

    2. Strategic Partnership and Collaboration

      • Serve as a strategic partner on Regulatory Networks and Matrix Teams.
      • Provide regulatory direction to cross-functional teams (e.g., Biopharmaceuticals, Pharma Supply Chain, Clinical Trial Supply, Quality Assurance, and Commercial) on global projects and strategic business initiatives.

    3. Regulatory Support for Inspections and Quality Incidents

      • Lead CMC regulatory strategy for major inspections (e.g., PAI’s) and quality incidents (e.g., PIRCs), ensuring that regulatory requirements are met and maintained.

    4. In-Licensing and Divestment Projects

      • Participate in corporate evaluations and provide CMC regulatory support for in-licensing and divestment projects.

    5. Problem Solving and Risk Mitigation

      • Direct multiple project activities and strategies, including managing staff, as applicable.
      • Formulate and implement novel approaches, systems, and processes for enhancing CMC regulatory functions.
      • Proactively identify key risks to the business and communicate well-defined risk mitigation strategies to senior management.

    6. Process Improvement and Strategy Execution

      • Create, evaluate, and continuously improve CMC regulatory processes, policies, and systems to enhance efficiency and quality.
      • Ensure all regulatory aspects are in place to support clinical trials, product release, and stability, avoiding clinical holds and ensuring continuity of supply.

    Impact of Decisions

    • Ensure strategic CMC regulatory aspects are addressed for clinical trials, product release, and stability, safeguarding market supply and approval timelines.
    • Maintain manufacturing flexibility and innovation while meeting regulatory requirements in marketing applications.
    • Lead change control requests, supporting supply transfers within GSK or with third parties to meet regulatory requirements and agreed timelines.

    Qualifications

    Basic Qualifications

    We are looking for professionals with the following skills and qualifications:

    • Biological sciences degree
    • Significant direct experience in CMC Regulatory
    • Proven experience leading key CMC regulatory activities for investigational and/or early commercial biopharmaceuticals
    • Experience with new drug applications in the US or EU
    • Strong Regulatory strategy development and execution skills

    Preferred Qualifications

    The following qualifications are a plus:

    • Advanced biological sciences degree
    • Proven CMC regulatory project leadership experience with biological medicines
    • Ability to demonstrate flexible thinking and resilience in fast-paced, dynamic environments
    • Strong capability to manage changing priorities effectively

    Why GSK?

    At GSK, we provide a dynamic and inclusive environment where employees thrive. We offer:

    • Competitive salary and annual bonus based on company performance
    • Comprehensive healthcare and well-being programs
    • Pension plans and shares and savings programs
    • A hybrid working model, offering flexibility between remote and in-office work
    • Career growth opportunities in a supportive, innovative culture

    Application Instructions

    To apply, please submit your CV and cover letter detailing how your experience aligns with the responsibilities and qualifications for this role.

    Equal Opportunity Employer

    GSK is an Equal Opportunity Employer. We provide equal consideration for employment without discrimination based on neurodiversity, race, color, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, veteran status, or any other protected class.

    Important Notice to Employment Agencies

    GSK does not accept referrals from employment agencies for vacancies posted on this site. Agencies must obtain prior written consent from GSK’s HR or Procurement Department before submitting candidates. Without such consent, GSK will not be liable for any fees.

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