Global Program Regulatory Manager Job in New Jersey (NJ), Research and Development Career, Full Time Jobs in Novartis Pharmaceuticals
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Global Program Regulatory Manager job in East Hanover

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Novartis Pharmaceuticals jobs
New Jersey (NJ), East Hanover
Job Code:  248431BR
Employer:  Novartis Pharmaceuticals
Category:  Research and Development
Job Type:  Full Time

Location
Country:  United States
State:  New Jersey (NJ)
City:  East Hanover
Map: 
09/05/2018

Description
The GPRM works with some independence under limited supervision to provide strategic and operational regulatory direction and may support the DRA global program team (GPT) representative and/or 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 DRA GPT representative and/or GTAL. In certain cases, the GPRM may act as the GPT representative. The GPRM is a member of the DRA subteam and may indirectly report to the DRA GPT representative for the project and may have responsibility for leading regional DRA subteams.
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).
ref: (248431BR)
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