Associate Director, Global Regulatory Affairs- Distributor Management

Social network you want to login/join with: Associate Director, Global Regulatory Affairs- Distributor Management, Uxbridge col-narrow-left Client: Gilead Sciences International, Ltd. Location: Uxbridge, United Kingdom Job Category: Other – EU work permit required: Yes col-narrow-right Job Reference: 4963817c4174 Job Views: 5 Posted: 05.05.2025 Expiry Date: 19.06.2025 col-wide Job Description: Description Summary: This is an exciting opportunity for an Associate Director, Regulatory Affairs to join the Gilead Global Regulatory Affiliates & Distributor team. The role involves oversight and management of regulatory activities by Gilead\’s in-market partners in the GPS region (South Asia, South-East and Central Asia, and Africa). The role requires effective stakeholder management and collaboration with regional leadership, cross-functional teams (Quality, Patient Safety, Trade Operations & Supply, Legal, Medical Affairs, Finance, and Access), Regulatory Therapeutic Area and CMC Liaisons, and in-market partners. The main goal is to oversee all regional regulatory activities, ensure high-quality and compliant services from partners, and align with commercial priorities. This role offers insight into commercial & access priorities, the in-market business model, and skill development for vendor oversight. The Associate Director, GPS Distributor Management, primarily oversees countries in Central and East Africa, including Botswana, Ethiopia, Malawi, Mauritius, Mozambique, Namibia, Uganda, Zambia, and Zimbabwe. Role and Responsibilities: Management of regulatory capability for Gilead’s in-market partners: Due diligence Distributor onboarding/offboarding Periodic regulatory training for partners Maintain oversight of legal agreements and understand their impact on regulatory activities Develop and propose regional and national regulatory strategies Maintain oversight and provide regulatory insights to optimize strategies throughout the product lifecycle Partner with the business to support commercial and access needs, aligning on priorities and filing strategies Identify and support resolution of emerging regulatory issues Provide regulatory input for product launches Interpret regulatory intelligence and local knowledge for strategic recommendations Comment on draft regulatory guidance/legislation in collaboration with stakeholders Participate in regional meetings and represent Gilead Regulatory externally Engage with Trade Associations as needed Liaise with manufacturing to plan and execute product packaging in compliance with regulations Support audits and inspections of in-market partners Core competencies: Experience in international regulatory affairs and submissions Knowledge of ICH and regional requirements Understanding of global and regional biopharmaceutical trends Experience with distributor markets and external vendors Leadership and cross-functional team management skills Excellent communication skills in English Strong planning and organizational skills Teamwork, analytical skills Education & Experience: Bachelor’s in Health or Pharmaceutical Sciences Significant Regulatory Affairs experience in Pharma/Biotech Experience with Regulatory Agencies and dossier preparation Proficiency in English Relationship-building and leadership skills Analytical and detail-oriented Technical skills in Microsoft Office; expertise in quality systems is a plus EEO Policy: Gilead Sciences is committed to equal employment opportunity, recruiting the most qualified persons without discrimination based on protected characteristics. For current employees: Please log onto your internal system to apply for this job. #J-18808-Ljbffr