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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
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.
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
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
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards