Associate Director, Global Regulatory Affairs- Distributor Management

Associate Director, Global Regulatory Affairs – Distributor Management, Cambridge

This is an exciting opportunity for an Associate Director, Regulatory Affairs to join Gilead\’s Global Regulatory Affiliates & Distributor team. The role involves overseeing regulatory activities of in-market partners in the GPS region (South Asia, South-East and Central Asia, and Africa).

The position requires effective stakeholder management, collaboration with regional leadership, cross-functional teams, and in-market partners. The main goal is to ensure regulatory activities meet Gilead’s standards and align with commercial priorities. The role covers countries in Central and East Africa, including Botswana, Ethiopia, Malawi, Mauritius, Mozambique, Namibia, Uganda, Zambia, and Zimbabwe.

Key Responsibilities:

• Manage regulatory capabilities of in-market partners, including due diligence, onboarding, and training.
• Oversee legal agreements impacting regulatory activities.
• Develop and propose regional and national regulatory strategies.
• Support product launch activities and resolve emerging regulatory issues.
• Provide regulatory insights and contribute to regional meetings and external engagements.

Core Competencies:

• Experience in international regulatory affairs and submission processes.
• Knowledge of ICH and regional regulatory requirements.
• Ability to lead cross-functional teams and develop regulatory strategies.
• Excellent communication skills in English and interpersonal skills.

Education & Experience:

• Bachelor’s degree in Health or Pharmaceutical Sciences.
• Significant regulatory affairs experience, including working with regulatory agencies and dossier preparation.
• Strong relationship-building and leadership skills.

Additional Information:

Gilead is committed to equal employment opportunity and prohibits discrimination based on protected characteristics.

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