Summary
About the Role
Position Title : Senior Global Program Regulatory Manager
Job Purpose:
The Sr GPRM works independently under limited supervision to provide strategic and operational regulatory direction and may support the DRA global program team (GPT) representative and/or GTAL for programs through development, registration and approval/post approval. The Sr GPRM ensures the execution of regulatory plans in line with global regulatory strategy in close collaboration with the RA global program team (GPT) representative and/or GTAL. In certain cases, the GPRM may be the GPT representative. The Sr GPRM is a member of the DRA sub team and may indirectly report to the DRA GPT representative for the project and has responsibility for leading regional RA sub teams.
Major Responsibilities:
Regulatory Strategy
• Provides input to global program regulatory strategy, including regulatory designations & innovative approaches
• May provide global RA leadership for specific part of the program or act as RA program lead for program of limited complexity
• Represents RA or leads in regional RA or cross-functional activities
• Determines requirements and coordinates activities for Health Authority (HA) interactions. May lead HAs meetings together with RA program lead.
• May serve as local HA liaison (e.g., FDA or EMA).
Regulatory Submissions
• Leads planning, preparation and submission of clinical trials.
• Coordinates, plans, and prepares for submission of initial registration and post-approval applications, including authoring of Module 1 documents
Regulatory Excellence and Compliance
• Ensures timely RA input and submission of regulatory compliance and maintenance reports (e.g. aggregate safety reports, annual reports, renewals, etc) across assigned regions
Role Requirements :
Education
Bachelors degree preferred (Minimum/desirable)
• Science based BS or MS. Advanced degree (e.g., MD, PhD, PharmD, regulatory) preferred
• Advanced understanding of pharmaceutical development, clinical trials, analysis and interpretation of scientific data
• Awareness of post-marketing/brand optimization strategies and commercial aspects.
• ≥4 years involvement in regulatory and pharmaceutical development spanning activities in Phases I-IV in 1 or more major region.
• Experience in leading cross-functional teams
• Strong collaboration, communication influencing and problem solving skills.
• Organizational awareness (e.g., interrelationship of departments, business priorities)
Why Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
