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    Director, Regulatory Affairs - Specialty

    Gsk Plc
    10+ years
    Not Disclosed
    London Stevenage
    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 - Specialty

    Location Options:

    • London, United Kingdom
    • Stevenage, United Kingdom
    • Wavre, Belgium

    Category: Regulatory
    Posted Date: January 9, 2025

    Company Overview

    GSK is a global biopharmaceutical company committed to uniting science, technology, and talent to get ahead of disease together. We focus on preventing and treating diseases through vaccines, specialty, and general medicines. We are driven by a shared ambition to positively impact the health of billions of people worldwide. Our success depends on the people behind the science, and we offer an inclusive environment where every individual can thrive.

    Role Overview

    The Director, Regulatory Affairs - Specialty is responsible for developing and executing regional regulatory strategies for assigned assets, ensuring alignment with the global regulatory approach and compliance with internal GSK policies and regional regulatory requirements. This role requires close collaboration with various cross-functional teams and direct interactions with local/regional regulatory authorities.

    Key Responsibilities

    1. Regulatory Strategy Development and Execution

      • Accountable to the Global Regulatory Leader (GRL) and Global Regulatory Therapeutic Area (TA) Head for the development and delivery of regional and/or global regulatory strategies.
      • Ensure the regulatory strategy aligns with the Medicines Development Strategy and local region needs while considering global perspectives.
      • Lead the implementation of regional strategies to support global project goals.

    2. Stakeholder Collaboration and Leadership

      • Serve as the single point of contact for assigned asset(s), responsible for managing regulatory strategy across both regional and global platforms.
      • Collaborate closely with local/regional commercial teams to secure the best possible labeling based on available data.
      • Lead regulatory interactions and represent GSK in meetings with local and regional regulatory authorities.
      • Engage with senior leaders within GSK and regulatory officials to advocate for regulatory approaches.

    3. Regulatory Compliance and Oversight

      • Ensure compliance with regional regulatory requirements throughout the product lifecycle, from C2MD to post-market.
      • Lead the regulatory review processes for local regions and provide input into the broader global strategy.
      • Assess potential in-licensing molecules for their regulatory compliance and feasibility.

    4. Cross-functional Leadership and Communication

      • Drive collaboration across multiple teams within GSK to ensure alignment and successful regulatory strategy execution.
      • Provide regulatory advice and ensure effective communication on all aspects of regional regulatory submissions and strategies.

    Qualifications

    Basic Qualifications

    To be considered for this role, candidates should have:

    • Bachelor’s degree
    • Experience in Regulatory Affairs within a pharmaceutical organization
    • Demonstrated experience working with Global Health Authorities and managing regulatory submissions for pharmaceutical products

    Preferred Qualifications

    Candidates with the following qualifications will be given priority:

    • PhD or Master’s degree in life sciences or pharmacy
    • Strong technical knowledge to assess regulatory compliance of pharmaceutical products
    • Proven ability to interact with regulatory officials and support advocacy initiatives

    Why GSK?

    At GSK, we are united in our mission to get ahead of disease together. Our success depends on the talent and passion of our people. 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
    • Opportunities for career growth in an inclusive and innovative environment

    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.

    Application Instructions

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

    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. Without such consent, GSK will not be liable for any fees.

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    Warsaw |

    Remote :

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

    Bucharest :

    Bucharest |

    Makkah :

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

    Nišava District :

    Niš |

    Singapore :

    Singapore |

    South Africa :

    South Africa | Midrand |

    Brazil :

    Brazil | Sao paulo |

    South America :

    Peru | Argentina |

    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 |