Senior Global Program Regulatory Manager job in East Hanover
|Employer:|| Novartis Pharmaceuticals|
|Category:||Research and Development|
|Job Type:||Full Time|
|State:||New Jersey (NJ)|
The Senior Global Program Regulatory Manager (Sr. GPRM) works independently under limited supervision to provide strategic andoperational regulatory direction and supports the Regulatory Affairs (RA) global program team (GPT) representative and/or Global Therapeutic Area Lead (GTAL) for programs through development, registration and approval/post approval in the BF IHC. The Senior GPRM ensures the execution of regulatory plans in line with global regulatory strategy in close collaboration with the RA global program team (GPT) representative and/or GTAL. The Sr. GPRM is a member of the DRA subteam and may indirectly report to the RA GPT representative for the project and has responsibility for leading regional DRA subteams.Responsible for implementing regulatory strategy and managing operational activities for assigned regions.?? Provides input into global regulatory strategy and contributes to Regulatory Functional Plan(RFP) and Seed Document, or their equivalents, including identification of gaps or risks in global strategic plan for assigned regions.?? Partners with regions to align on regulatory strategy in order to fulfil business objectives.?? Implements RFP across assigned regions.?? Works with RA GPT representative and/or GTAL to plan and facilitate presentations toNovartis regulatory boards on regulatory strategy.?? Works with RA GPT representative and/or GTAL to interact with regulatoryconsultants/advisors for global strategic input and challenge.?? Develops and implements regulatory readiness with other line functions, Country PharmaOrganizations|
• Contributes to the development of the Development Core Data Sheet (DCDS) and Core Data
Sheet (CDS) with RA GPT representative and/or GTAL, consistent with development data and
commercial objectives of the TPP.
• Generates local PIs, ensuring that they are integrated with the CDS, TPP and regulatory
strategy, and are commercially competitive.
• Identifies potential label issues/gaps and develops regulatory label negotiation strategy with
• Revises label as needed to achieve timely HA approval with best possible label based on data
• Responsible for ensuring necessary updates or required reviews of local labeling and to
capture deviations to maintain alignment with the CDS in conjunction with DRA GL.
Regional Excellence and Compliance
• Responsible for finalization and on time submission of annual reports and renewals across
• Responsible for appropriate entering and quality of product specific attributes in compliance
• Ensures regulatory compliance for project and keeps records of all major HA interactions in
the validated document management system.
• Ensures quality and compliance with global regulatory requirements (regions responsible)
and adherence to regulatory internal policies and processes.
• Provide support as needed for non-project related regional excellence activities.
• Reviews promotional and non-promotional materials and press releases in as required and
works with RA GPT representative and/or GTAL to ensure messages are consistent with
Novartis policies and guidelines.
Key Performance Indicators (Indicate how performance for this role will be measured)cience based BS or MS with requisite experience and demonstrated
capability. Advanced degree (MD, Ph D, PharmD) preferred.
Languages: Fluency in English as a business language. Additional language is an asset.
Experience: • Strong knowledge of regulatory submission and approval processes in 1
or more major regions.
• Experience leading regulatory submissions and approvals in at least 1
• Experience in a global/matrix environment or cross-functional teams in
the pharmaceutical industry.
• Experience in HA negotiations.
• 4-6 years involvement in regulatory and drug/biologic development
spanning activities in Phases I-IV in the following areas:
1. Innovation in regulatory strategy.
2. Prior history with post-marketing/brand optimization
strategies and commercial awareness preferred.
3. Involvement in dossier submissions and approvals.
4. HA negotiations
5. Drug regulatory submissions and commercialization in
6. Proven ability to analyze and interpret efficacy and safety
7. Regulatory operational expertise.
Strong interpersonal, communication, negotiation and problem solving
Organizational awareness (e.g., interrelationship of departments,