US-NJ, Senior Global Program Regulatory Manager 213689BR-MZ
Senior 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 Global Therapeutic Area Lead. In certain cases, the Global Program Regulatory Manager may be the Global Program Team representative. The Sr. GPRM is a member of the DRA subteam and may indirectly report to the Reg Affairs GPT representative for the project and has responsibility for leading regional Reg Affairs subteams.
Regulatory Strategy 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 Reg Affairs Global Program Team representative and/or GTAL to plan and facilitate presentations to Novartis regulatory boards on regulatory strategy. Works with Reg Affairs GPT representative and/or GTAL to interact with regulatory consultants/advisors for global strategic input and challenge. Develops and implements regulatory readiness with other line functions, Country Pharma Organizations and key opinion leaders, and ensures integration with global regulatory readiness with Reg Affairs GPT representative and/or GTAL. Represents Reg Affairs on or leads sub-teams as required. HA Interactions Determines requirements and sets objectives for Health Authority (HA) interactions with Reg Affairs GPT representative and/or GTAL. Facilitates preparation and finalization of briefing books and contributes to preparation of summary documents. Develops and implements plans for timely response to HA requests and coordinates responses. Leads rehearsals for HA meetings as appropriate. Leads HA meetings independently or with Reg Affairs GPT representative and/or GTAL as appropriate. May serve as local HA liaison depending on location (e.g., FDA or EMA). Submissions and Approvals Implements strategy across regions in line with global strategy. Identifies issues, gaps, and trade-offs affecting optimal and timely submission and approval. Proposes options to minimize risk. Drives coordination, planning, and submission of dossiers in assigned regions worldwide. Review of global dossier summary documents. Develops and implements plans to avoid/minimize clock stops during submission review. Reviews, approves and submits Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs). Reviews and submits Risk Management Plans. May lead negotiations for regional approvals independently or with Reg Affairs GPT representative and/or GTAL. Responsible for facilitating timely submission and approval of dossier with HAs under the guidance of the Reg Affairs GPT representative and/or GTAL.
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 Strong knowledge of regulatory submission and approval processes in 1 or more major regions. Experience leading regulatory submissions and approvals in at least 1 major region. 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 major regions. 3 6. Proven ability to analyze and interpret efficacy and safety data. 7. Regulatory operational expertise. Strong interpersonal, communication, negotiation and problem solving skills
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