Beschreibung
Global Program Regulatory Manager (GPRM)
Your tasks
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 DRA GPT representative and/or GTAL to plan and facilitate presentations to company regulatory boards on regulatory strategy
- Coordinates and implements regulatory readiness with other line functions, Country Pharma Organizations and key opinion leaders.
HA Interactions
- Determines requirements and sets objectives for Health Authority (HA) interactions with DRA 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.
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 DRA GPT representative and/or GTAL.
- Responsible for facilitating timely submission and approval of dossiers with HAs under the guidance of the DRA GPT representative and/or GTAL.
Prescribing Information
- Contributes to the development of the Development Core Data Sheet (DCDS) and Core Data Sheet (CDS)with DRA GPT representative and/or GTAL, consistent with development data and commercial objectives of the TPP.
- Assists with generating local PIs and ensuring that they are integrated with the CDS,TPPand regulatory strategy, and are commercially competitive.
- Contributes to identifying potential label issues/gaps and develops regulatory label negotiation strategy with contingency planning.
- Revise labels as needed to achieve timely HA approval with best possible label based on available data.
- Responsible for ensuring necessary updates or required reviews of local labeling and to capture deviations to maintain alignment with the CDS in conjunction with DRA GL.
Regional Excellence and Compliance
- Responsible for finalization and on time submission of annual reports and renewals across assigned regions.
- Responsible for appropriate entering and quality of product specific attributes in compliance database.
- Ensures regulatory compliance for assigned project and keeps records of all major HA interactions in the validated document management system.
- Ensures quality and compliance with global regulatory requirements (regions responsible) and adherence to regulatory internal policies and processes.
- Provide support as needed for non-project related regional excellence activities.
Your profile
Education (minimum/desirable):
Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred.
Languages:
Fluency in English as a business language. Additional language is an asset.
Experience:
- 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:
- Strong interpersonal, communication, negotiation and problem solving skills.
- Basic organizational awareness (eg, interrelationship of departments, business priorities).