Join Novartis in Regulatory Affairs
At Novartis, your voice, experience, and quality mindset can truly make a difference in Regulatory Affairs (RA). Novartis has a unique and promising portfolio with 70 projects as potential NMEs in development, 65 projects in Phase 3 or already undergoing registration, and 100 Phase 1/2 projects. We also focus on rare disease areas; in fact, more than 80% of our innovation is targeted on areas of high unmet need. In many cases, we can offer family-friendly work flexibility to facilitate your physical and mental health. We hope you will consider joining our global OneRA family.
Role Overview
The Sr GPRM works under limited supervision of the regulatory affairs (RA) program lead to develop and implement the global regulatory strategy for program(s) through development, registration, and post-approval in the assigned region(s). They may act as the RA program lead on programs of limited complexity. The Sr GPRM is a member of the RA sub team and may lead or represent RA in regional or cross-functional teams. They may also act as a subject matter expert and/or assume a mentoring role.
Major Accountabilities
* Regulatory Strategy
o Provides input to global program regulatory strategy, including regulatory designations & innovative approaches.
o May provide global RA leadership for specific parts of the program or act as RA program lead for programs of limited complexity.
o Represents RA or leads in regional RA or cross-functional activities.
o Determines requirements and coordinates activities for Health Authority (HA) interactions. May lead HA meetings together with RA program lead.
o May serve as local HA liaison (e.g., FDA or EMA).
* Regulatory Submissions
o Leads planning, preparation, and submission of clinical trials.
o Coordinates, plans, and prepares for submission of initial registration and post-approval applications, including authoring of Module 1 documents.
* Regulatory Excellence and Compliance
o Ensures timely RA input and submission of regulatory compliance and maintenance reports (e.g., aggregate safety reports, annual reports, renewals, etc.) across assigned regions.
Education and Experience
* Bachelor's 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 regions.
* Experience in leading cross-functional teams.
* Strong collaboration, communication, influencing, and problem-solving skills.
* Organizational awareness (e.g., interrelationship of departments, business priorities).
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