Job Description
This job is with Novartis, an inclusive employer and a member of myGwork – the largest global platform for the + business community. Please do not contact the recruiter directly.
Summary: 1,800+ associates, 86 countries, One Regulatory Affairs. At Novartis, your voice, experience, and quality mindset can truly make a difference in Regulatory Affairs (RA). Our portfolio includes 70 projects as potential NMEs in development, 65 projects in Phase 3 or already undergoing registration, and 100 Phase 1/2 projects. We focus on rare disease areas; over 80% of our innovation targets high unmet needs. We offer family-friendly work flexibility to support your physical and mental health. Read on to learn about the role available in Regulatory Affairs. We hope you will consider joining our global OneRA family.
Hybrid work model: on-site requirements of 3 days a week (12 days a month).
Note: We are unable to offer permit support for this role.
About the Role
The Sr GPRM works under limited supervision of the RA program lead to develop and implement the global regulatory strategy for programs through development, registration, and post-approval in the assigned regions. They may act as the RA program lead on programs of limited complexity and represent RA in regional or cross-functional teams. They may also serve as a subject matter expert or mentor.
Major Accountabilities
Regulatory Strategy
* Provides input to global program regulatory strategy, including designations & innovative approaches.
* May provide global RA leadership for specific parts of the program or act as RA program lead for limited complexity programs.
* Represents RA or leads in regional RA or cross-functional activities.
* Coordinates activities for Health Authority interactions, potentially leading HA meetings with the 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 and prepares for submission of registration and post-approval applications, including authoring Module 1 documents.
Regulatory Excellence and Compliance
* Ensures timely RA input and submission of compliance and maintenance reports (e.g., safety reports, annual reports, renewals) across regions.
Education
* Bachelor's degree (minimum/desirable).
* Science-based BS or MS; advanced degrees (e.g., MD, PhD, PharmD, regulatory) are a plus.
* Strong understanding of pharmaceutical development, clinical trials, and scientific data interpretation.
* Awareness of post-marketing strategies and commercial aspects.
* ≥4 years in regulatory and pharmaceutical development activities (Phases I-IV) in one or more major regions.
* Experience leading cross-functional teams.
* Strong collaboration, communication, influencing, and problem-solving skills.
* Organizational awareness of interdepartmental relationships and business priorities.
Why Novartis
Helping people with disease and their families requires more than science. It takes a community of passionate, collaborative individuals like you. Join us to create breakthroughs that change lives. https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network
Not the right role? Sign up to our talent community to stay connected and learn about opportunities: https://talentnetwork.novartis.com/network
Benefits and Rewards
Learn about how we support your growth: https://www.novartis.com/careers/benefits-rewards
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