Global Program Regulatory Director / Global Program Regulatory Directress

Job ID: REQ-10050556

Date: May 08, 2025

Location: Switzerland

Summary

Our Development Team is driven by a clear purpose: to reimagine medicine in order to improve and extend the lives of individuals. To achieve this, we are optimizing our processes and investing in new technologies, building specific therapeutic areas and enhancing our capabilities—all to deliver our medicines to patients more efficiently.

We invite talented individuals like you to join us in this mission and help create a brighter future for those affected by diseases and their families.

Apply online using the form below, and embark on a journey to reimagine new medicines with us!

The Role

As the Global Program Regulatory Director, you will provide global leadership throughout the lifecycle of development and marketed product programs. Your expertise will ensure that input from global health authorities, regional teams, and functional collaborators is compiled to formulate a coherent global regulatory strategy that meets product profile and portfolio objectives.

You will also identify regulatory opportunities, mitigate potential issues, and ensure the effective execution of regulatory strategies across regions. Furthermore, you will lead global regulatory sub-teams, share your regulatory and development expertise, and represent the Regulatory Affairs function on cross-functional initiatives and committees.

About the Role

Major Accountabilities

• Develop, document, and communicate high-quality global regulatory strategies and health authority interactions in collaboration with multiple stakeholders to achieve business objectives.
• Evaluate and communicate potential global regulatory opportunities and risks while developing mitigation strategies.
• Leverage regional expertise in executing global regulatory strategies and engaging with health authorities.
• Provide strategic regulatory input into the analysis and interpretation of scientific data and key documentation.
• Utilize scientific knowledge and acumen to analyze, interpret, and communicate data effectively to colleagues while leading interactions with Regulatory Affairs and Development Unit management and external consultants for input to regulatory strategies.
• Maintain Novartis core product information documents throughout the product lifecycle, in conjunction with regulatory labeling responsibilities.
• Contribute to any Business Development and Licensing (BD&L) due diligence activities.

Regulatory Excellence & Compliance

• Ensure compliance with global regulatory requirements and adherence to internal regulatory policies and processes, coordinating regulatory compliance activities at a global level.
• Offer support for non-project related excellence activities as needed.

People

• Act as an effective matrix leader by providing feedback and mentoring to team members, line functions, and sub-teams. Collaborate with line managers to create growth and development opportunities for team members, leading by example and embodying Novartis values and behaviors.

Your Experience

• Bachelor's or master's degree in a science-related field; advanced degree is desirable.
• Significant experience in regulatory and pharmaceutical development across Phases I-IV.
• A proven track record of working effectively with health authority guidance and feedback, negotiations, and post-marketing/brand optimization strategies.
• Demonstrated leadership success across a wide range of regulatory and pharmaceutical development activities.
• Strong interpersonal skills with experience in navigating complex, cross-functional organizations and leading teams.
• Fluency in English.

Why Novartis?

Our goal is to reimagine medicine to improve and extend lives, and we aspire to be the most valued and trusted medicines company globally. Achieving this depends on our people—our associates drive our ambitions forward each day. Be part of this mission and join us!

Learn more about our strategy and culture here.

Commitment to Diversity and Inclusion

Novartis is dedicated to fostering an inclusive work environment and building diverse teams that mirror the patients and communities we serve.

Accessibility & Accommodation

We are committed to providing reasonable accommodations to all individuals. If you require reasonable accommodation for any part of the recruitment process due to a medical condition or disability, please reach out to us at Show e-mailm">Show e-mail with your request and contact information. Be sure to include the job requisition number in your message.

Join Our Novartis Network

If this role does not align with your experience or career goals, but you want to remain connected and learn about future opportunities, please join the Novartis Network.

Benefits and Rewards

Discover all the ways we support your personal and professional growth in the Novartis Life Handbook: here.

Only applications matching the job profile will be considered.