Senior Global Program Regulatory Manager - Immunology

Novartis; London; On-site; GBP 70,000 - 100,000; Full time

Job summary

Join Novartis as a Senior Global Program Regulatory Manager to lead regulatory strategies in immunology. You will oversee submission processes, ensure compliance, and mentor teams while enjoying flexible work arrangements. This role is critical for advancing innovative projects targeting unmet medical needs.

Qualifications

• Experience in developing global regulatory strategies.
• Strong understanding of regulatory compliance and submissions.
• Ability to lead cross-functional teams.

Responsibilities

• Contribute to and lead regulatory strategies for programs.
• Manage clinical trial applications and registration document submissions.
• Ensure compliance with health authority regulations and timely report submissions.

Job description

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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: 4

Posted: 02.06.2025

Expiry Date: 17.07.2025

Job Description:

Join Novartis, a global leader with over 1,800 associates across 86 countries, in the Regulatory Affairs (RA) department. We focus on innovative projects, including rare diseases, with a high percentage of our portfolio targeting unmet needs. We offer flexible work arrangements to support your well-being. The Senior Global Program Regulatory Manager (Sr GPRM) works under limited supervision to develop and implement global regulatory strategies for assigned programs, possibly leading programs of limited complexity. They are part of the RA team, may lead regional or cross-functional teams, and act as a subject matter expert or mentor.

Major Accountabilities:

• Regulatory Strategy: Contribute to global regulatory strategies, provide leadership for specific program parts, represent RA in regional or cross-functional activities, coordinate health authority interactions, and serve as local HA liaison if needed.
• Regulatory Submissions: Lead planning and submission of clinical trial applications and other registration documents.
• Regulatory Excellence and Compliance: Ensure timely submission of compliance reports, safety reports, and renewals across regions.