Senior Global Program Regulatory Manager - Immunology

Senior Global Program Regulatory Manager - Immunology, London

Client:

Novartis

Location:

London, United Kingdom

Job Category:

Other

EU work permit required:

Yes

Job Reference:

11fca1b6fda4

Job Views:

7

Posted:

02.04.2025

Expiry Date:

17.05.2025

Job Description:

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). 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. Read on to learn about the role available in Regulatory Affairs. We hope you will consider joining our global OneRA family.

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 mentoring role.

Major accountabilities:

1. 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).
2. 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
3. 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

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Created on 02/04/2025 by TN United Kingdom