US-NJ, Sr. Global Program Regulatory Manager 218442BR-MZ
Sr. Global Program Regulatory Manager
Global Drug Development
REG AFFAIRS GDD
East Hanover, NJ
Research & Development
The Senior Global Program Regulatory Manager works independently under limited supervision to provide strategic and operational regulatory direction and may support the Reg Affairs Global Program Team (GPT) representative and/or Global Therapeutic Area Lead (GTAL) for programs through development, registration and approval/post approval. The Senior GPRM ensures the execution of regulatory plans in line with global regulatory strategy in close collaboration with the Reg Affairs Global Program Team (GPT) representative and/or GTAL. In certain cases, the GPRM may be the GPT representative. The Sr. GPRM is a member of the Reg Affairs subteam and may indirectly report to the Reg Affairs GPT representative for the project and has responsibility for leading regional Reg Affairs subteams.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
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
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