Global Program Regulatory Director / Global Program Regulatory Directress

Job ID

REQ-10050556

Date: May 08, 2025

Location: Switzerland

Summary

Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people's lives. To achieve this, we are optimizing and strengthening our processes and ways of working. By investing in new technologies and building specific therapeutic area and platform depth and capabilities, we aim to bring our medicines to patients even faster.

We are seeking key talent, like you, to join us in giving people with diseases and their families a brighter future to look forward to.

Apply online using the form below.

The Role

As a Global Program Regulatory Director, you will provide global leadership throughout the lifecycle of development and/or marketed product programs. Your expertise will be essential in collating input from global health authorities, regional, and functional collaborators to construct a coherent global regulatory strategy that meets target product profile and portfolio objectives.

Your responsibilities will also include identifying regulatory opportunities, mitigating potential issues, and ensuring the execution of regulatory strategies across regions. Additionally, you will lead global regulatory sub-teams, share your regulatory and development expertise, and represent the Regulatory Affairs function in cross-functional initiatives and committees.

About the Role

Major Accountabilities:

Regulatory Strategy & Submissions

• Develop, document, and communicate high-quality global regulatory strategies and health authority interactions with multiple stakeholders to achieve business objectives.
• Evaluate and communicate potential global regulatory opportunities and risks, and develop mitigation strategies.
• Leverage regional expertise to execute global regulatory strategy and health authority engagement.
• Provide strategic regulatory input into the analysis and interpretation of scientific data and key documentation.
• Utilize scientific knowledge in data analysis and communication, leading interactions with Regulatory Affairs and Development Unit management and external consultants for regulatory strategy input.
• Accountable, in conjunction with regulatory labeling, for maintaining Novartis core product information documents throughout the product lifecycle.
• Contribute to any business development and licensing due diligence activities.

Regulatory Excellence & Compliance

• Ensure compliance with global regulatory requirements and adherence to internal policies and processes, coordinating regulatory compliance activities 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, line functions, and sub-teams. Collaborate with line managers to create opportunities for team member growth and development, embodying Novartis values and behaviors.

Your Experience:

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

Why Novartis?

Our purpose is to reimagine medicine to improve and extend people's lives, and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. Our associates drive us each day to reach our ambitions. Be a part of this mission and join us!

Learn more here: Novartis People and Culture

Commitment to Diversity and Inclusion

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Accessibility & Accommodation

Novartis is dedicated to providing reasonable accommodation to all individuals. If, due to a medical condition or disability, you require accommodation for any part of the recruitment process, please send an email to diversity.inclusion_ch@novartis.com and let us know the nature of your request along with your contact information. Please include the job requisition number in your message.

Join our Novartis Network

If this role is not suitable for your experience or career goals, but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here.

Benefits and Rewards

Read our handbook to learn more about how we help you thrive personally and professionally: Novartis Benefits and Rewards

Division & Location

Division: Development

Business Unit: Universal Hierarchy Node

Location: Switzerland

Site: Basel (City)

Company / Legal Entity: C028 (FCRS = CH028) Novartis Pharma AG

Functional Area: Research & Development

Job Type: Full-time

Employment Type: Regular

Shift Work: No