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    Eq Regulatory Compliance Lead

    Gsk Plc
    GSK plc
    5+ years
    Not Disclosed
    Remote Australia Remote, USA
    10 Jan. 17, 2025
    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, 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

    External Quality Regulatory Compliance Lead - GSK

    Location Options:

    • UK – London – New Oxford Street
    • Belgium – Wavre
    • France – Evreux
    • France – Mayenne
    • Spain – Aranda de Duero, Burgos
    • Canada – Mississauga Milverton Drive
    • UK – County Durham – Barnard Castle
    • UK – Hertfordshire – Ware
    • USA – Upper Merion, Maryland – Rockville, North Carolina – Durham, North Carolina – Zebulon

    Posted Date: January 8, 2025
    Closing Date for Applications: January 29, 2025

    At GSK, we’re committed to making a difference in the health and well-being of billions of people around the world. We offer competitive salaries, benefits, and flexible working options as part of our Performance with Choice program, allowing a balance between remote and office work.

    About the Role:

    We are seeking an External Quality Regulatory Compliance Lead to play a critical role in driving business transformation within our regulatory and quality processes. This global role offers significant exposure, interaction with multiple stakeholders, and a great opportunity for career development.

    Key Responsibilities:

    • Regulatory Compliance Guidance: Advise on regulatory compliance by interpreting registered details, regulatory advice, corporate standards, and authority commitments.
    • Consultancy: Provide expert consultancy on regulatory compliance and conformance topics.
    • Regulatory Intelligence: Monitor and interpret new legislation and regulatory changes, ensuring business impact is clearly communicated to stakeholders.
    • Process Ownership: Lead and improve quality change control processes, linking them to regulatory systems (e.g., Veeva), quality regulatory intelligence, and pharmacopoeial compliance.
    • Performance Management: Ensure processes are followed and manage performance using defined metrics.
    • Training & Development: Deliver training on regulatory compliance processes as needed.
    • Cross-functional Collaboration: Serve as the interface between Regulatory Compliance, GRA, and External Manufacturing teams, ensuring smooth implementation of regulatory requirements.

    Essential Qualifications & Skills:

    • A degree in science, engineering, or equivalent experience.
    • Significant experience in a quality function in a regulated pharmaceutical environment.
    • Strong prioritization and problem-solving skills in complex environments.
    • Experience in continuous improvement processes and/or certification.

    Preferred Qualifications & Skills:

    • Experience with change control processes and regulatory compliance.
    • Familiarity with Veeva systems for regulatory documentation and change control.
    • Ability to influence stakeholders at all levels.
    • Experience with Small Molecule, Biologics, or Vaccines.

    Why GSK?

    At GSK, we unite science, technology, and talent to make a difference in the health of patients worldwide. Join us as we deliver transformational vaccines and medicines and transform the future of healthcare. We foster a work environment that values growth, inclusivity, and well-being.

    GSK is an equal opportunity employer, promoting diversity in our workforce. We are committed to providing an inclusive workplace where everyone feels valued.

    Application Instructions:

    Please submit your application, including your CV or cover letter, by January 29, 2025. Ensure you highlight how your experience aligns with the competencies required for this role.

    For further information, visit the Life at GSK webpage.

     

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    Remote :

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

    Republic of Colombia :

    Bogota |

    Williamson :

    Brentwood |

    Bucharest :

    Bucharest |

    Buenos Aires :

    Buenos Aires |

    Republic of Egypt :

    Cairo |

    Mexico :

    New Mexico | Ciudad de México |

    Dubai :

    Dubai |

    Makkah :

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

    Kuala Lumpur :

    Kuala Lumpur |

    Kyiv Oblast :

    Kyiv |

    Lima Region :

    Lima |

    France :

    Lyon | Paris |

    South Africa :

    South Africa | Midrand |

    Nišava District :

    Niš |

    Bohemia :

    Prague |

    Chile :

    Santiago |

    Bosnia and Herzegovina :

    Sarajevo |

    Singapore :

    Singapore |

    Sofia City :

    Sofia |

    Sweden :

    Sweden |

    Taipei :

    Taipei |

    Mazovia :

    Warsaw |