About the role

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:

Proven regulatory leadership experience within the pharmaceutical industry, spanning 8–10 years
Expertise in end-to-end regulatory portfolio management, including innovative and complex product pipelines
Strong track record of engagement with global Health Authorities, driving successful regulatory outcomes
Demonstrated leadership in building, mentoring, and strengthening high-performing teams
Solid experience in operations management, ensuring effective execution and delivery of regulatory objectives
Experienced in leading organizational restructuring and driving change management initiatives
Recognized contribution to policy development and shaping of regulatory frameworks

Skills Desired

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

Skills & Tags

Aplyr's read

Novartis is a Swiss-based global healthcare leader, known for its focus on innovative medicines and commitment to addressing patient needs through diverse roles.
Synthesized from recent postings & public sources

What's promising

•Novartis invests heavily in research and development, driving innovation in pharmaceuticals.
•The company offers a wide range of global career opportunities across various fields.
•Strong focus on cutting-edge therapies, including gene therapy and AI-driven solutions.

What to watch

•Regulatory challenges can impact the speed of drug approval and market entry.
•High competition in the pharmaceutical industry requires constant innovation to maintain market position.
•Complex organizational structure may slow decision-making processes.

Why Novartis

•Novartis has a robust pipeline of innovative medicines, setting it apart in the healthcare sector.
•The company emphasizes a diverse and inclusive workplace culture across its global operations.
•Novartis is a leader in digital transformation within pharmaceuticals, integrating AI and data science.

Aplyr’s read is generated by AI from public sources. Was it useful?

About Novartis

Novartis

novartis.com

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Novartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide. It focuses on innovative medicines, generics, and eye care.