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    Director Of Regulatory Business Excellence

    Gsk Plc
    10+ years
    Not Disclosed
    London Poland Stevenage United Kingdom
    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

    Director of Regulatory Business Excellence
    Location: Poznan, Poland; London, United Kingdom; Stevenage, United Kingdom
    Category: Regulatory
    Job ID: 410615
    Posted Date: January 8, 2025
    Closing Date for Applications: January 24, 2025 (COB)

    About GSK

    GSK is a global biopharma company dedicated to uniting science, technology, and talent to get ahead of disease. We focus on preventing and treating diseases with vaccines, specialty, and general medicines. Our core therapeutic areas include infectious diseases, HIV, respiratory/immunology, and oncology. We want to make GSK a place where people can thrive and grow, while being inspired and encouraged to be their best. Join us in this exciting moment in our journey to get Ahead Together.

    Role Overview

    Are you a strategic leader passionate about driving business excellence and fostering a culture of learning? GSK is looking for a Director of Regulatory Business Excellence to play a pivotal role in shaping the future of our Global Regulatory Affairs (GRA) organisation.

    In this front-facing leadership role, you will be responsible for designing and implementing capability frameworks, training matrices, and change management campaigns to ensure our teams are equipped, compliant, and supported to excel. Your efforts will ensure that the GRA teams are aligned and adaptable to evolving ways of working, ultimately driving business success.

    Key Responsibilities

    • Regulatory Business Excellence Strategy: Develop and implement a strategy to align with GRA objectives and address skills and capability gaps through regular reviews and analyses.
    • Training Framework: Design and maintain a comprehensive training framework, ensuring staff are trained, compliant, and supported while continuously monitoring and improving its effectiveness.
    • Change Management: Lead and drive change management initiatives, collaborating with cross-functional teams to ensure smooth adoption of new initiatives and innovations.
    • Continuous Improvement Culture: Foster a culture of continuous improvement through mentorship, coaching, and the promotion of business excellence methodologies.
    • Subject Matter Experts (SMEs) Forum: Build and engage a forum of SMEs to define functional requirements and enhance organizational capabilities.
    • Team Resource Management: Work closely with the Head of Regulatory Excellence to effectively manage team resources and deliver on key priorities.

    Basic Qualifications & Skills

    We are looking for professionals with the following skills to achieve our goals:

    • Qualification: A qualification in a scientific or technical specialization.
    • Experience: Extensive experience in training and change management with a proven ability to implement impactful change in large organizations.
    • Communication: Excellent communication skills (both oral and written), with the ability to tailor approaches to different audiences.
    • Problem Solving: Strong problem-solving abilities, learning agility, and situational awareness, with the ability to navigate ambiguity.
    • Project Management: Robust project management skills, including the ability to manage competing priorities and deliver high-quality outputs under pressure.
    • Industry Knowledge: Experience in pharmaceutical drug development, a strong understanding of global regulatory procedures, and familiarity with complex IT systems in regulated environments.
    • Leadership: Demonstrated leadership experience in managing teams or matrix teams, fostering collaboration, and driving results.

    Preferred Qualifications & Skills

    While not necessary, the following skills are preferred:

    • Education: BSc (or equivalent) in a scientific or technical discipline.
    • Innovation & Collaboration: Demonstrated success in driving innovation and building high-performing global matrix team relationships.
    • GSK IT Applications: Knowledge of GSK IT applications and systems supporting GRA, with an understanding of Regulatory Affairs roles and responsibilities.

    Why GSK?

    At GSK, we offer:

    • Competitive Salary & Annual Bonus: Based on company performance.
    • Healthcare & Wellbeing Programs: Comprehensive coverage for your wellbeing.
    • Pension Plan & Shares Program: For long-term security.
    • Hybrid Working Model: Empowering you to balance remote and in-office work through our Performance with Choice program.

    Equal Opportunity Employer

    GSK is an Equal Opportunity/Affirmative Action Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive equal consideration for employment regardless of race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, or veteran status.

    Application Instructions

    To apply, please use the ‘cover letter’ section of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information you provide in your cover letter and CV will be used to assess your application.

    Important Notice to Employment Businesses/Agencies:
    GSK does not accept referrals from employment businesses or agencies without prior written authorization. Employment businesses/agencies must contact GSK’s commercial and general procurement/human resources department for written authorization before referring candidates.

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    Remote Korea :

    Remote Korea |

    Republic of Korea :

    Seoul |

    Kuala Lumpur :

    Kuala Lumpur |

    Mexico :

    Ciudad de México |

    New Zealand :

    New Zealand |

    North Island :

    Auckland |

    Lima Region :

    Lima |

    Cebu Province :

    Cebu City |

    Philippines :

    Manila |

    Mazovia :

    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 |