Job Description

Responsibilities:

The Sr GPRM works under limited supervision of the regulatory affairs (RA) program lead to develop and implement the global regulatory strategy for program(s) through development, registration and post approval in the assigned region(s).
The Sr GPRM may act as subject matter expert and/or assume mentoring role.
Provides input to global program regulatory strategy, including regulatory designations & innovative approaches.
May provide global RA leadership for specific part of the program e.g. new indication, new formulation or act as RA program lead for program of limited complexity.
Coordinates regulatory readiness with other line functions, Country Organizations & Regions.
Represents RA or leads in regional RA or cross-functional activities.
Provides strategic input to cross functional deliverables (e.g. protocols, IB, safety reports etc).
Contributes to the development and maintenance of the Core Data Sheet (CDS).
Determines requirements and coordinates activities for Health Authority (HA) interactions.
May lead HAs meetings together with RA program lead.
May serve as local HA liaison (e.g., FDA or EMA).
Leads planning, preparation and submission of clinical trials.
Leads implementation of the defined global registration strategy into regional submissions worldwide by country organizations.
Coordinates, plans, and prepares for submission of initial registration and post-approval applications, including authoring of Module 1 documents.
Contributes to preparation, review and maintenance of local product information in their assigned region.
Leads regulatory activities during HA reviews including response to questions and HA interactions.
Ensures timely RA input and submission of regulatory compliance and maintenance reports (e.g. aggregate safety reports, annual reports, renewals, etc) across assigned regions.
Maintains regulatory information in compliance databases and document management systems.
May serve as RA subject matter expert.
May assume mentoring role.

Requirements:

Experience 4 years involvement in regulatory and pharmaceutical development spanning activities in Phases I-IV in 1 or more major region.
Experience in leading cross-functional teams.
Strong collaboration, communication influencing and problem-solving skills.
In LCM, the Sr GPRM may report to the LCM-(Sr)GPRD and focus on one of the following subject matter expertise.
Maintenance: preparation of selected global regulatory submissions (eg Annual, aggregate safety reports, renewals, variations, etc.) for assigned portfolio.
Portfolio Transformation: portfolio streamlining activities.
pruning and deregistration, divestment/integration, RxGx, portfolio transformation and manufacturing production transfer as applicable.

* Ladders Estimates