Regional Regulatory Lead

Responsibilities

• Provide oversight for the branded Viatris portfolio in assigned African countries, developing and executing regulatory strategies for new registrations and post-approval submissions.
• Manage post-approval strategy and execution, ensuring alignment with supply chain, labeling, and CMC teams to deliver submission-ready dossiers.
• Oversee complex post-approval submissions, such as technical transfers, from the planning stage through to approval.
• Ensure all regulatory documentation meets local requirements regarding content, consistency, and completeness.
• Maintain regulatory systems and databases in accordance with internal SOPs and policies.
• Collaborate with stakeholders, including Product Strategists and in-market teams, to drive efficiencies in regulatory processes.
• Manage renewal processes for assigned markets to ensure timely submissions.
• Supervise and manage Regional Regulatory Lifecycle Strategists, Managers, or contractors as required.

Requirements

• Bachelor's degree in Chemistry, Pharmacy, or a related life sciences field.
• Minimum of 8 years of experience in regulatory affairs, preferably with human medicines.
• Proven experience in regional regulatory environments and product lifecycle management.
• Technical competence in understanding and interpreting CMC submissions and identifying potential risks.
• Strong knowledge of drug development, pharmaceutical regulations, and guidelines.
• Demonstrated ability to manage complex regulatory issues and deliver results within time, cost, and quality standards.
• Excellent leadership, communication, negotiation, and interpersonal skills.
• Ability to work effectively in a matrix environment and make strategic decisions.

About the Company

Viatris is a global healthcare company dedicated to providing access to medicines and improving patient outcomes worldwide. Formed in 2020 through the combination of Mylan and Upjohn, Viatris leverages best-in-class scientific, manufacturing, and distribution expertise to deliver high-quality medicines to approximately 1 billion patients annually.