Global Program Regulatory Manager (Neuroscience)

Global Program Regulatory Manager (Neuroscience)

Job ID REQ-

Mar 26, 2025

United Kingdom

Summary

As Global Program Regulatory Manager, you will work with the support of a 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). The Global Program Regulatory Manager is also a member of the Regulatory Affairs sub team and may lead or represent RA in regional or cross functional teams.

About the Role

Key Responsibilities:

Regulatory Strategy

• Provide input to global program regulatory strategy, including regulatory designations & innovative approaches.
• Coordinates regulatory readiness with other line functions, Country Organizations & Regions, representing Regulatory Affairs (RA) or leads in regional RA or cross-functional activities providing strategic input into cross functional deliverables.
• Contributes to the development and maintenance of key documents, determines the requirements and coordinates the activity for Health Authority (HA) interactions.

Regulatory Submissions

• Leads planning, preparation and submission of clinical trials.
• Leads implementation of the defined global registration strategy into regional submissions worldwide by country organizations.
• Coordinates, plans and prepares for submission of initial registrations and post approval applications, and the preparation, review and maintenance of local product information as assigned.
• Lead regulatory activities during HA reviews, responding to questions and HA interactions.

Regulatory Excellence & Compliance

• Ensures timely RA input and submission of regulatory compliance and maintenance reports, maintaining regulatory information in compliance databases and document management systems.
• Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred.
• Experience with regulatory submission and approval processes in 1 or more major regions.
• Experience in a global/matrix environment or cross-functional teams in the pharmaceutical industry.
• Experience in HA negotiations.
• 2-4 years involvement in regulatory and drug/biologic development spanning activities in Phases I-IV in the following areas:
• Innovation in regulatory strategy.
• Understanding of post-marketing/brand optimization strategies and commercial awareness preferred.
• Involvement in dossier submissions and approvals HA negotiations Drug regulatory submission and commercialization in region.
• Analysis and interpretation efficacy and safety data.
• Regulatory operational expertise.
• Strong interpersonal, communication, negotiation and problem-solving skills.
• Basic organizational awareness (e.g., interrelationship of departments, business priorities).

Location: UK, London Hybrid working requirement 3 days / 12 days per month in office.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?

Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Functional Area: Research & Development

Job Type: Full time

Employment Type: Regular

Shift Work: No