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 to improve and extend people's lives.

To achieve this, we are continuously optimizing our processes and investing in new technologies to build specific therapeutic areas and platform capabilities, all aimed at delivering our medicines to patients more efficiently.

We are seeking exceptional talent like you to join us in giving those with diseases and their families a brighter future to anticipate.

Apply online using the form below.

The Role

As a Global Program Regulatory Director, you will provide global leadership throughout the lifecycle of product development and marketing programs. Your expertise will ensure that input from global health authorities, regional teams, and functional collaborators is synthesized into a coherent regulatory strategy that aligns with our target product profile and portfolio objectives.

You will be tasked with identifying regulatory opportunities, mitigating potential issues, and ensuring the successful execution of regulatory strategies across regions. Additionally, you will lead global regulatory sub-teams, impart your regulatory and development knowledge, and represent the Regulatory Affairs function in cross-functional initiatives and committees.

About the Role

Major Accountabilities:

• Regulatory Strategy & Submissions:
  • Collaborate with multiple stakeholders to develop, document, and communicate high-quality global regulatory strategies and health authority interactions to achieve business objectives.
  • Assess and communicate potential global regulatory opportunities and risks, creating effective mitigation strategies.
  • Utilize regional expertise in executing global regulatory strategies and health authority engagement.
  • Provide strategic regulatory input into the analysis and interpretation of scientific data and key documentation.
  • Leverage scientific knowledge in the communication of data to colleagues and lead interactions with Regulatory Affairs and Development Unit management and external consultants.
  • Maintain Novartis core product information documents throughout the product lifecycle in collaboration with regulatory labeling.
  • Contribute to business development and licensing due diligence activities.
• Regulatory Excellence & Compliance:
  • Ensure compliance with global regulatory requirements and adherence to internal policies and processes at a global level.
  • Provide support for non-project-related excellence activities as needed.
• People:
  • As an effective matrix leader, provide feedback and mentorship to team members and sub-teams. Collaborate with line managers to facilitate growth and development opportunities, embodying Novartis values and behaviors.

Your Experience

• Science-based bachelor's or master's degree; advanced degree preferred.
• Significant experience in regulatory affairs and pharmaceutical development across Phases I-IV.
• A proven history of working with health authority guidance, feedback, and negotiations, along with post-marketing strategies and regulatory operations.
• Demonstrated leadership success across a wide range of regulatory and pharmaceutical development activities.
• Strong interpersonal skills with experience working in complex, cross-functional organizations.
• Fluency in English.

Why Novartis?

Our purpose is to reimagine medicine to improve and extend people's lives, and we aspire to be the most valued and trusted medicines company globally. This vision is made possible due to our dedicated workforce. Be a part of this mission and join us!

Learn more here: Novartis People and Culture

Benefits and Rewards

For comprehensive information about our benefits and rewards, please refer to the Novartis Life Handbook: Benefits and Rewards.

Commitment to Diversity and Inclusion

Novartis is committed to fostering an outstanding, inclusive work environment with diverse teams that reflect the patients and communities we serve.

Accessibility & Accommodation

If you require reasonable accommodation during the recruitment process due to a medical condition or disability, please contact Show e-mailm">Show e-mail with your request and contact information, including the job requisition number.

Join Our Network

If this role does not align with your experience or career goals, but you wish to stay connected and hear about future opportunities at Novartis, please join the Novartis Network: Novartis Talent Network.

Creating a Brighter Future Together

At Novartis, impacting the lives of people affected by disease requires more than innovative science; it necessitates a community of intelligent, passionate individuals working together to achieve remarkable breakthroughs. Are you ready to join us in shaping a brighter future?

For additional information, please visit: Novartis About Us.

Job Details

Division: Development

Business Unit: Universal Hierarchy Node

Location: Switzerland

Site: Basel (City)

Company / Legal Entity: Novartis Pharma AG

Functional Area: Research & Development

Job Type: Full-time

Employment Type: Regular

Shift Work: No