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    Executive Director And Head Established Products Therapeutic Group

    Gsk Plc
    10+ years
    Not Disclosed
    Collegeville London Massachusetts Switzerland
    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: Executive Director and Head, Established Products Therapeutic Group

    Location Options:

    • Collegeville, Pennsylvania, USA
    • Rixensart, Belgium
    • London, United Kingdom
    • Waltham, Massachusetts, USA
    • Zug, Switzerland

    Category: Regulatory
    Posted Date: December 11, 2024

    Company Overview:

    GSK is a global biopharmaceutical company with a clear purpose: to unite science, technology, and talent to get ahead of disease together. Our focus areas include vaccines, specialty medicines, and general medicines, with emphasis on infectious diseases, HIV, respiratory/immunology, and oncology. We are committed to advancing medical discovery through innovation and are determined to positively impact the health of billions of people worldwide. Our success is driven by our people, and we aim to create an inclusive environment where everyone can thrive.

    Role Overview:

    The Executive Director and Head, Established Products Therapeutic Group will play a pivotal role in shaping regulatory strategies for the Established Products (EP) portfolio. This position will require strategic leadership to oversee and direct regulatory activities related to the life cycle management of EP products, including market expansion, divestment, and discontinuation strategies. The role also involves extensive collaboration across functions within GSK and representation with external regulatory agencies.

    The Executive Director will be directly responsible for regulatory filings, interactions with regulatory authorities, and ensuring that regulatory activities are in line with business goals and regulatory requirements. This role will also oversee budget, staffing, and operations within the team.

    Key Responsibilities:

    1. Leadership of Regulatory Activities:

      • Oversee and direct all regulatory activities for the EP product portfolio.
      • Ensure alignment of regulatory strategies with business objectives by working across the regulatory matrix with other functions within GSK.

    2. Strategic Planning & Life Cycle Management:

      • Contribute to the creation and implementation of product life cycle plans that incorporate effective regulatory strategies.
      • Drive the regulatory strategy for market expansion, divestment, and discontinuation as part of portfolio optimization.

    3. Stakeholder Collaboration:

      • Serve as the regulatory business partner to the General Medicine commercial leadership team and PALT, ensuring regulatory risks are managed and regulatory obligations are met.
      • Lead regulatory efforts for portfolio optimization and represent regulatory activities in senior decision-making forums such as the Portfolio Optimization Board.

    4. Regulatory Strategy and Policy Development:

      • Lead the formulation and execution of global regulatory strategies and assist in the development and implementation of policies to optimize product stewardship.
      • Anticipate and monitor regulatory, scientific, and legal issues that may impact the business, advising management on potential implications.

    5. External Agency Interactions:

      • Act as a credible spokesperson with external regulatory agencies, ensuring proactive communication and fostering collaborative approaches to agency interactions.
      • Work with external stakeholders to shape the regulatory environment in alignment with GSK principles.

    6. Leadership and Team Development:

      • Lead the development of regulatory capabilities to support changing business strategies and evolving market needs.
      • Manage the regulatory team, ensuring effective resource allocation, budget oversight, and continuous development.

    Why You?

    Basic Qualifications:

    We are looking for professionals who meet the following criteria:

    • Bachelor’s degree in a relevant field
    • 10+ years of experience in Regulatory Affairs
    • Proven line-management experience in leading teams

    Preferred Qualifications:

    The following qualifications would be advantageous:

    • PhD in a relevant field
    • Extensive knowledge in a relevant therapeutic area or a proven ability to rapidly acquire expertise in a new area.
    • Proven experience in leading product development, submissions, and approval activities, including successful milestone meetings and strong relationships with health authorities.
    • In-depth knowledge of clinical trial, licensing, supply chain, and life cycle management requirements in major markets, with experience in global regulatory leadership.

    Why GSK?

    At GSK, we aim to provide a working environment where people can grow and 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, allowing flexibility between remote and in-office work
    • Opportunities for career growth in a dynamic, inclusive environment

    Application Instructions:

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

    Equal Opportunity Employer:

    GSK is an Equal Opportunity Employer. We provide equal consideration for employment without discrimination based on race, color, national origin, religion, sex, 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. All agencies must obtain prior written consent from GSK’s HR or Procurement Department before submitting candidates. Failure to do so will result in no fees being paid by GSK.

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