GPRM/RegCMC Senior Manager
Posted on Feb 4, 2021 by Harvey Nash IT Recruitment Switzerland
For our client in Basel we are searching for GPRM/RegCMC Senior Manager for 6 months project
Job Title: GPRM/RegCMC Senior Manager
Duration: 22/02/2021 to 22/08/2021
The Sr GPRM works independently 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 Sr GPRM ensures the execution of regulatory plans in line with global regulatory strategy in close collaboration with the RA global program team (GPT) representative and/or GTAL. In certain cases, the GPRM may be the GPT representative. The Sr GPRM is a member of the DRA sub team and may indirectly report to the DRA GPT representative for the project and has responsibility for leading regional RA sub teams.
1. Responsible for implementing regulatory strategy and managing operational activities for assigned regions.
2. 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.
3. Partners with regions to align on regulatory strategy in order to fulfil business objectives
4. Implements RFP across assigned regions.
5. Works with RA GPT representative and/or GTAL to plan and facilitate presentations to the company's regulatory boards on regulatory strategy.
6. Works with RA GPT representative and/or GTAL to interact with regulatory consultants/advisors for global strategic input and challenge.
7. Develops and implements regulatory readiness with other line functions, Country Pharma
8. Organizations and key opinion leaders, and ensures integration with global regulatory readiness with RA GPT representative and/or GTAL.
9. Represents RA on or leads sub-teams as required.
1. Determines requirements and sets objectives for Health Authority (HA) interactions with RA GPT representative and/or GTAL.
2. Facilitates preparation and finalization of briefing books and contributes to preparation of summary documents.
3. Develops and implements plans for timely response to HA requests and coordinates responses.
4. Leads rehearsals for HA meetings as appropriate.
5. Leads HA meetings independently or with RA GPT representative and/or GTAL as appropriate.
6. May serve as local HA liaison depending on location (eg, FDA or EMA).
Submissions and Approvals
1. Implements strategy across regions in line with global strategy.
2. Identifies issues, gaps, and trade-offs affecting optimal and timely submission and approval.
3. Proposes options to minimize risk.
4. Drives coordination, planning, and submission of dossiers in assigned regions worldwide.
5. Review of global dossier summary documents.
6. Develops and implements plans to avoid/minimize clock stops during submission review.
7. Reviews, approves and submits Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs).
8. Reviews and submits Risk Management Plans.
9. May lead negotiations for regional approvals independently or with RA GPT representative and/or GTAL.
10. Responsible for facilitating timely submission and approval of dossier with HAs under the guidance of the RA GPT representative and/or GTAL.
1. Contributes to the development of the Development Core Data Sheet (DCDS) and Core Data Sheet (CDS) with RA GPT representative and/or GTAL, consistent with development data and commercial objectives of the TPP.
2. Generates local PIs, ensuring that they are integrated with the CDS, TPP and regulatory strategy, and are commercially competitive.
3. Identifies potential label issues/gaps and develops regulatory label negotiation strategy with contingency planning.
4. Revises label as needed to achieve timely HA approval with best possible label based on data available.
5. Responsible for ensuring necessary updates or required reviews of local labeling and to capture deviations to maintain alignment with the CDS in conjunction with RA GL.
Regional Excellence and Compliance
1. Responsible for finalization and on time submission of annual reports and renewals across assigned regions.
2. Responsible for appropriate entering and quality of product specific attributes in compliance database.
3. Ensures regulatory compliance for assigned project and keeps records of all major HA interactions in the validated document management system.
4. Ensures quality and compliance with global regulatory requirements (regions responsible) and adherence to regulatory internal policies and processes.
5. Provide support as needed for non-project related regional excellence activities.
1. Reviews promotional and non-promotional materials and press releases as required and work with RA GPT representative and/or GTAL to ensure messages are consistent with the company's policies and guidelines.
2. Successful implementation of global regulatory strategy for timely submissions and approvals with the best possible labels based on available data.
3. Identification of main HA issues for Seed Document.
4. Participation in relevant Regulatory Boards leading to valuable input from these Boards.
5. Successful participation in HA interactions to achieve business objectives.
6. Provides comprehensive regulatory feedback to achieve global business objectives