Description de l'offre
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 (RA) 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 RA 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.
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 fullfill business objectives. Implements RFP across assigned regions. Works with RA GPT representative and/or GTAL to plan and facilitate presentations to Novartis regulatory boards on regulatory strategy Coordinates and implements regulatory readiness with other line functions, Country Pharma Organizations and key opinion leaders. Works with RA GPT representative and/or GTAL to interact with regulatory consultants/advisors for strategy input and challenge. Represents RA on or leads sub-teams as required. HA Interactions Determines requirements and sets objectives for Health Authority (HA) interactions with RA GPT representative and/or GTAL. Interacts directly with HAs as appropriate in meetings with DRA GPT representative and/or GTAL. Coordinates and plans rehearsals for HA meetings. Facilitates preparation and finalization of briefing books. Develops and implements plans for timely response to HA requests and coordinates responses. May serve as local HA liaison depending on location (e.g., FDA or EMA). Submissions and Approvals Responsible for integrating global strategy into regional submissions worldwide. Contributes to identification of issues, gaps, and tradeoffs affecting optimal and timely submission and approval. Coordinates, plans, and prepares for submission of dossiers in assigned regions worldwide. Review of global dossier summary documents. Contributes to development and implementation of plans to avoid/minimize clock stops during submission review. Responsible for submission of Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs). Participates in negotiations for approvals as required with RA GPT representative and/or GTAL. Responsible for facilitating timely submission and approval of dossiers with HAs under the guidance of the RA GPT representative and/or GTAL. Prescribing Information • Contributes to the development of the Development Core Data Sheet (DCDS) and Core Data Sheet (CDS)with RA GPT representative
Global Program Regulatory Manager/ Sr. Global Program Regulatory
Global Program Regulatory Manager - 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).
Sr. Global Program Regulatory Manager - Experience:
• 3-4 years of regulatory experience, preferably with a strong knowledge of US regulatory affairs. Additional knowledge of other regions is an asset.
• Oncology background highly preferred.
• Additional drug development experience in discovery research, CMC, preclinical pharmacology, toxicology, clinical development or other experimentally based discipline is an asset.
• Involvement in an IND/CTA submissions and approval.
• Regulatory operational expertise
• Experience with HA negotiations
• Innovation and strategy
• Experience working in matrix environment or cross-functional teams.
• Strong interpersonal, communication, negotiation and problem solving skills
Research & Development
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.