Job Description Summary

Provide strategic leadership of Regulatory Affairs at the country level, driving the development and execution of forward-looking regulatory strategies that ensure timely approvals, sustained compliance, and accelerated patient access.
Act as a key business partner and member of the country leadership team, shaping decisions through proactive regulatory insights, risk anticipation, and solution-oriented thinking. Lead efforts to influence the external regulatory environment by building strong Health Authority partnerships and contributing to policy evolution that supports innovation and access to medicines.
Champion a high-performance regulatory organization that balances operational excellence with strategic agility, leveraging digital tools, data, and regulatory intelligence to enhance efficiency, transparency, and decision-making. Ultimately, enable sustainable business growth and maximize portfolio value by embedding regulatory strategy at the core of business planning and execution

 

Job Description

Key Accountabilities:

• Lead and define the country regulatory strategy aligned with global and regional objectives to ensure timely approvals and sustainable market access.
• Oversee end-to-end regulatory activities across the portfolio (development, registration, lifecycle management), ensuring full compliance with local health authority requirements.
• Act as the primary interface with Health Authorities, building strong, credible relationships to shape regulatory outcomes and influence policy where appropriate.
• Ensure regulatory compliance and governance, including adherence to internal policies, quality standards, and evolving local regulations.
• Provide strategic input to cross-functional teams (Medical, Market Access, Commercial, Development) to optimize submission strategies and maximize product value.
• Lead, coach, and develop the local RA team, building capabilities, ensuring talent growth, and fostering a high-performance and compliant culture.
• Drive regulatory intelligence and policy awareness, anticipating changes in the regulatory landscape and translating them into actionable strategies.
• Ensure timely and high-quality submissions and approvals, proactively identifying risks, resolving issues, and accelerating timelines wherever possible.
• Represent Regulatory Affairs in country leadership teams, contributing to business decisions and ensuring regulatory perspectives are embedded early.
• Champion digitalization and process excellence in RA, leveraging tools and data to enhance efficiency, transparency, and decision-making.

Minimum Requirements:

 

Skills Desired

Clinical Trials, Cross-Functional Teams, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Problem Solving Skills, Regulatory Compliance, Risk Management