Global Program Regulatory Manager (Neuroscience)

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

Essential Requirements:

• 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?  https://www.novartis.com/about/strategy/people-and-culture

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

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