Associate Director, Global Regulatory Affairs- Distributor Management

TN United Kingdom; Uxbridge; On-site; GBP 80,000 - 120,000; Full time

Job summary

An exciting opportunity awaits a skilled Associate Director in Regulatory Affairs to join a dynamic team overseeing regulatory activities across multiple regions. This role involves collaborating with diverse stakeholders to ensure compliance and align with commercial priorities. The successful candidate will manage regulatory strategies, support product launches, and provide insights into biopharmaceutical trends. Join a forward-thinking organization committed to excellence and make a significant impact in the healthcare sector while developing your leadership and analytical skills.

Qualifications

• Experience in international regulatory affairs and submissions.
• Knowledge of ICH and regional requirements.

Responsibilities

• Manage regulatory capability for in-market partners.
• Develop and propose regional regulatory strategies.

Skills

International Regulatory Affairs

Leadership Skills

Communication Skills

Analytical Skills

Planning and Organizational Skills

Education

Bachelor’s in Health or Pharmaceutical Sciences

Significant Regulatory Affairs Experience

Tools

Microsoft Office

Quality Systems

Job description

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Associate Director, Global Regulatory Affairs- Distributor Management, Uxbridge

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Client:

Gilead Sciences International, Ltd.

Location:

Uxbridge, United Kingdom

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

4963817c4174

Job Views:

5

Posted:

05.05.2025

Expiry Date:

19.06.2025

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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:

1. 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:

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