Global Program Regulatory Manager

For our client in BASEL we are looking for a GLOBAL PROGRAM REGULATORY MANAGER for a 12-MONTH contract.

DURATION: 01/03/2018 TO 28/02/2019

LOCATION: BASEL

WORKLOAD: 100%

JOB PURPOSE

The GPRM works with some independence under limited supervision to provide strategic and operational regulatory direction and may support the GPRD 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 GPRD. 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 GPRD for the project and may have responsibility for leading regional DRA subteams.

Major Accountabilities

Regulatory Strategy
§ Responsible for implementing regulatory strategy and managing operational activities for assigned regions.
§ Provides input into global regulatory strategy and 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.
§ Works with GPRD to plan and facilitate presentations to regulatory boards on regulatory strategy
§ Coordinates and implements regulatory readiness with other line functions, Country Pharma Organizations and key opinion leaders.
§ Works with GPRD to interact with regulatory consultants/advisors for strategy input and challenge.
§ Represents DRA on or leads sub-teams as required.

HA INTERACTIONS
§ Determines requirements and sets objectives for Health Authority (HA) interactions with GPRD
§ Interacts directly with HAs as appropriate in meetings with GPRD
§ 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 (eg, 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 GPRD
§ Responsible for facilitating timely submission and approval of dossiers with HAs under the guidance of the GPRD.

Prescribing Information
Contributes to the development of the Development Core Data Sheet (DCDS) and Core Data Sheet (CDS) with GPRD, consistent with development data and commercial objectives of the TPP.
Assists with generating local PIs and ensuring that they are integrated with the CDS, TPP and 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.
Promotional/Non-promotional Review
Reviews promotional and non-promotional materials and press releases as required and works GPRD to ensure messages are consistent with policies and guidelines.

REQUIREMENTS:

EDUCATION
- 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:

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.
6. Analysis and interpretation efficacy and safety data.
7. Regulatory operational expertise.

For further details please contact Beata Arciszewska:
email: (see below)