Global Program Regulatory Director (Life Cycle Management)

Job Description

26 major approvals. 13 major submissions. 2,000 associates worldwide. That was Regulatory Affairs in 2020. We are a culturally diverse, global team of talented professionals seeking to leverage the voices of our patients in our approach to bringing potentially life-changing therapies to people who need them. Novartis has a robust pipeline, including possible treatments for rare disease conditionals with unmet needs.

We are expanding our global team and encourage you to consider a career in Regulatory Affairs at Novartis. Working collaboratively and interactively thanks to our technology, we have been as connected as ever—OneRA as we call it. We pride ourselves on our patient-focused mindset and dedication, which allow us to work closely with colleagues, share knowledge, and strive to reimagine medicine.

Joining the Life Cycle Management (LCM) team you will be able to contribute efforts towards the successful development of novel therapies or combination of therapies to fight cancer, achieve health authorities’ approvals and enable patients’ access to new treatment options to improve and extend their lives. Don’t miss this opportunity to reimagine medicine!

Your Responsibilities Include, but are not limited to:
• Lead and supervise assigned regulatory liaisons (8-10 direct reports) across three GDD sites (Basel/East Hanover/Hyderabad) responsible for regulatory life cycle of marketed products within the assigned Therapeutic Area
• Provide regulatory direction to assigned LCM portfolio
• Ensure high quality and globally aligned regulatory documents to achieve optimal life cycle management submission
• Leverage regional expertise and ensure that Regional/CPO input is sought and incorporated into global regulatory LCM strategy
• Ensure appropriate TA input and consistency of HA interactions and registration activities within and across TAs in line with global strategy
• Ensure high quality and professional interactions with HAs globally including participation in key formal and informal HA contacts as required.
• Evaluate and clearly communicate to management regulatory risks/gaps and trade-offs for the overall LCM plan and develop mitigation/contingency plans for identified risks

EEO Statement
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Minimum requirements

What You'll Bring to the role:
• Science based BS or MS with requisite experience and proven capability. Advanced degree (MD, Ph D, PharmD) preferred
• Experience with regulatory submission, HA negotiations and approval processes in major regions
• Previous people management and/or extensive coaching experience
• Minimum 6-8 years of regulatory and drug/biologic development experience, in most or all of the following areas:
o Life cycle/ post-approval phase
o 2-5 years of proven leadership and accomplishment in all aspects of regulatory affairs in a global/matrix environment in the pharmaceutical industry.
o Global matrix management experience desirable
o Good management, interpersonal, communication, negotiation and problem solving skills
o Good organizational awareness (e.g., interrelationship of departments, business priorities), including experience working cross functionally, cross culturally and in global teams, and collaborating effectively with external development partners

Why consider Novartis?

769 million. That’s how many lives our products touched in 2020. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

Imagine what you could do at Novartis!

Commitment to Diversity & Inclusion:

Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

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