Senior Global Program Regulatory Manager - Immunology

TN United Kingdom; London; On-site; GBP 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Senior Global Program Regulatory Manager to join their dynamic team in London. In this pivotal role, you will develop and implement global regulatory strategies for innovative programs, ensuring compliance and timely submissions for clinical trials and regulatory applications. You will collaborate with cross-functional teams and represent regulatory affairs in critical interactions with health authorities. This role offers a unique opportunity to contribute to groundbreaking projects in the field of immunology while enjoying family-friendly work flexibility that supports your well-being. If you are passionate about making a difference in regulatory affairs, this position is perfect for you.

Benefits

Family-friendly work flexibility

Health and wellness support

Qualifications

• Experience in Regulatory Affairs with a focus on global strategies.
• Ability to lead regulatory submissions and ensure compliance.

Responsibilities

• Develop and implement global regulatory strategies for assigned programs.
• Lead planning and submission of clinical trials and regulatory applications.
• Ensure timely regulatory compliance and maintenance reports.

Skills

Regulatory Affairs

Regulatory Strategy Development

Clinical Trials Submission

Health Authority Interactions

Regulatory Compliance

Education

Bachelor's Degree in Life Sciences

Advanced Degree (e.g., Master's, PhD)

Job description

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

Please note that if you are NOT a passport holder of the country for the vacancy you might need a work permit.

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Created on 02/04/2025 by TN United Kingdom