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    Manager, Oncology Therapeutic Group, Global Regulatory Affairs

    Gsk Plc
    5+ years
    Not Disclosed
    London Stevenage 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 committed to advancing medical discovery through innovation. Our purpose is to unite science, technology, and talent to get ahead of disease together. Focused on vaccines, specialty medicines, and general medicines, we aim to positively impact the health of billions of people worldwide. We foster an environment where individuals can thrive, grow, and make a meaningful contribution to our success.

    Role Overview

    The Executive Director and Head of Established Products Therapeutic Group will lead and shape regulatory strategies for the Established Products (EP) portfolio. This role will involve strategic oversight of regulatory activities for product life cycle management, including market expansion, divestment, and discontinuation strategies. The position requires extensive collaboration across GSK functions and direct interaction with external regulatory agencies.

    Key responsibilities include regulatory filings, managing interactions with global regulatory authorities, and ensuring alignment of regulatory activities with business goals. The role also involves oversight of budget, staffing, and operations within the team.

    Key Responsibilities

    1. Leadership of Regulatory Activities

      • Oversee all regulatory activities for the EP product portfolio.
      • Ensure regulatory strategies are aligned with business goals by collaborating across the regulatory matrix with other functions within GSK.

    2. Strategic Planning & Life Cycle Management

      • Contribute to and implement product life cycle plans incorporating effective regulatory strategies.
      • Drive regulatory strategies 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.
      • Lead regulatory efforts for portfolio optimization and represent regulatory activities at senior decision-making forums, including the Portfolio Optimization Board.

    4. Regulatory Strategy and Policy Development

      • Lead the formulation and execution of global regulatory strategies.
      • Monitor and assess regulatory, scientific, and legal issues that may affect 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 relationships.
      • Work with external stakeholders to shape the regulatory environment in alignment with GSK principles.

    6. Leadership and Team Development

      • Develop regulatory capabilities to support evolving business strategies and market needs.
      • Oversee the regulatory team, ensuring effective resource allocation, budget management, and team development.

    Why You?

    Basic Qualifications:

    We seek 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 are highly desirable:

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

    Why GSK?

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

    • 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 dynamic environment

    Application Instructions

    To apply, please submit your CV and a cover letter describing 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 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. 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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    Ciudad de México |

    New Zealand :

    New Zealand |

    North Island :

    Auckland |

    Lima Region :

    Lima |

    Cebu Province :

    Cebu City |

    Philippines :

    Manila |

    Mazovia :

    Warsaw |

    Remote :

    Bountiful | Riga | Zaragoza | Blue Bell | Hammond | Leinster | Ireland | Lenexa | Hungary | Victoria | Remote | Slovakia | Remote - Middle East | Castlebar | Belgium | Remote, USA | Remote - Africa | Manipal | Texas | Remote - South America (Latin Americal) | Tulsa | Remote - Europe | Nairobi | Green Way | Medan | McFarland | Thailand | French | Minnesota | Faridabad | Melbourne | Lousiana | Springville | Switzerland | Xzagreb | Bishop |

    Bucharest :

    Bucharest |

    Makkah :

    Riyadh | King Abdullah Economic City | Rabigh | Jeddah | Najran | Khulais |

    Nišava District :

    Niš |

    Singapore :

    Singapore |

    South Africa :

    Midrand | South Africa |

    Brazil :

    Brazil | Sao paulo |

    South America :

    Argentina | Peru |

    Catalonia :

    Barcelona |

    Madrid :

    Madrid |

    Sweden :

    Sweden |

    Taipei :

    Taipei |

    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |

    Kyiv Oblast :

    Kyiv |

    Dubai :

    Dubai |

    Hà Nội :

    Hà Nội | Hanoi |

    Ho Chi Minh :

    Ho Chi Minh City |