US-NJ, Global Program Regulatory Manager 218457BR-MZ
Global Program Regulatory Manager
Global Drug Development
REG AFFAIRS GDD
East Hanover, NJ
Research & Development
The Global Program Regulatory Manager (GPRM) works with some independence under limited supervision to provide strategic and operational regulatory direction and may support the Regulatory Affairs Global Program Team (GPT) representative and/or Global Therapeutic Area Lead (GTAL) for programs through development, registration and approval/post approval. The GPRM ensures the execution of regulatory plans in line with global regulatory strategy in close collaboration with the Regulatory Affairs GPT representative and/or GTAL. In certain cases, the GPRM may act as the GPT representative. The GPRM is a member of the Regulatory Affairs sub-team and may indirectly report to the Regulatory Affairs GPT representative for the project and may have responsibility for leading regional Regulatory Affairs sub-teams.
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.
Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred. English 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: 1. Innovation in regulatory strategy. 2. Understanding of post-marketing/brand optimization strategies and commercial awareness preferred. 3. Involvement in an dossier submissions and approvals 4. HA negotiations. 5. Drug regulatory submission and commercialization in region. 3 6. Analysis and interpretation efficacy and safety data. 7. Regulatory operational expertise. Strong interpersonal, communication, negotiation and problem solving skills. Basic organizational awareness (e.g., interrelationship of departments, business priorities).
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