The Role
Lead country-level Regulatory Affairs strategy and operations to secure timely approvals, ensure compliance, engage Health Authorities, support cross-functional submissions, build high-performing teams, drive regulatory intelligence, digitalization, and policy influence to accelerate patient access and maximize portfolio value.
Summary Generated by Built In
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 ManagementSkills Required
- 8-10 years regulatory leadership experience in the pharmaceutical industry
- Expertise in end-to-end regulatory portfolio management including innovative and complex product pipelines
- Proven track record engaging with global Health Authorities and driving successful regulatory outcomes
- Demonstrated leadership in building, mentoring, and strengthening high-performing regulatory teams
- Solid operations management experience ensuring effective execution and delivery of regulatory objectives
- Experience leading organizational restructuring and driving change management initiatives
- Recognized contribution to policy development and shaping regulatory frameworks
- Clinical Trials knowledge
- Experience working with cross-functional teams (Medical, Market Access, Commercial, Development)
- Detail-oriented with strong negotiation and problem-solving skills
- Regulatory compliance and risk management experience
Novartis Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Novartis and has not been reviewed or approved by Novartis.
-
Healthcare Strength — Pay and benefits are described as a strong overall package, supported by medical, dental, and vision insurance alongside FSAs/HSAs and disability and life coverage. Mental-health support is reinforced through an employee assistance program with psychological support and a network of mental health first aiders.
-
Retirement Support — Retirement support is positioned as a standout element, with an automatic company contribution plus dollar-for-dollar matching in the 401(k). Additional retirement funding is described through an age-based defined contribution program and access to an employee share purchase plan discount.
-
Parental & Family Support — Family-related benefits are framed as robust, including a global minimum of paid parental leave for new parents following birth or adoption. Added supports include domestic partner coverage, dependent-care resources, and benefits such as adoption assistance and child/elder care options.
Novartis Insights
Am I A Good Fit?
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.
Success! Refresh the page to see how your skills align with this role.
The Company
What We Do
Novartis is an innovative medicines company. Every day, working to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.
