Sr Global Program Regulatory Manager (Associate Director) - Hematology

Sep 14, 2021

Job Description

26 major approvals, 13 major submissions and 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. Read on to learn what you could do as part of our closely knit team.

Joining the Hematology development team as a Senior Global Program Regulatory Manager, you will be able to contribute to continued successful development of a therapy for chronic myeloid leukemia and a medical counter measure for hematopoietic-acute radiation syndrome, achieving health authorities’ approvals and enabling patients’ access as quickly as possible.

Your accountabilities will include, but are not limited to:
• Provide input into global regulatory strategies and implement in assigned regions (focus US/LaCan) in collaboration with local teams
• Act as FDA and BARDA liaison for assigned products
• Represent Regulatory Affairs and lead regulatory and cross-functional sub-teams
• Lead or coordinate Health Authority meetings
• Contribute to the development of global and local labeling and review of promotional and non-promotional material
• Ensure regulatory compliance, e.g. keep records of relevant Health Authority interactions in document management system and compliance databases

Diversity & Inclusion / EEO

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 will bring to the role:
• Science based BS or MS. Advanced degree (MD, Ph D, PharmD) preferred
• 4-6 years involvement in regulatory and drug/biologic development spanning activities in Phases I-IV, including experience in leading regulatory submissions and approvals in at least 1 major region
• Experience in a global/matrix environment or cross functional teams in the pharmaceutical industry
• Strong interpersonal, communication, negotiation and problem solving skills
• Proven ability to analyze and interpret efficacy and safety data
• Proficiency in English as a business language. Additional language is an asset

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.

Join our Novartis Network:

If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here:
Global Drug Development
East Hanover, NJ
Research & Development
Full Time
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Sr Global Program Regulatory Manager (Associate Director) - Hematology

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