Junior Regulatory Project Manager - US Country Labelling

GSK•Durham, CA

About The Position

This role is responsible for the production, quality, and regulatory acceptability of manuscripts for new/revised prescribing information for products marketed in the US. The position involves identifying and resolving problems proactively, suggesting creative approaches to capture labeling concepts, and ensuring consistency in labeling documents across products. The Junior Regulatory Project Manager will work with Labeling Strategy staff to ensure compliance with US Labeling processes and effectively articulate FDA and GSK requirements to matrix teams. Key responsibilities include ensuring all labeling regulatory requirements are met, resolving labeling issues proactively, maintaining accurate version control of labeling submissions, and developing FDA-compliant XML labeling documents. The role also involves coordinating Drug Listing submissions, producing all required versions of prescribing information documents, and meeting project deadlines. The individual must be able to manage their time effectively, work on multiple projects in parallel, and provide summaries of Labeling updates for Annual Reports. The major outputs include providing regulatory advice regarding prescribing information requirements and ensuring US prescribing information meets all regulatory requirements and maintains proper version control. While this role does not require staff management, some training or mentoring may be necessary.

Requirements

Understanding of regulatory labeling requirements for US prescribing information submissions, and a detailed understanding of internal policies, procedures, and guidelines.
Proficient with computer software applications.
Familiarity with medical terminology.

Nice To Haves

Undergraduate Degree in a Science or Life Science area or equivalent practical experience.
Labeling and Regulatory experience in the pharmaceutical industry.
Knowledge of FDA regulations relevant to labeling.
Knowledge of XML labeling
Ability to negotiate solutions to labeling issues.
Ability to work on multiple projects with attention to detail.
Excellent written and oral communication skills.
Ability to work with project teams to resolve issues regarding prescribing information requirements.
Effectively builds positive relationships within Labeling team and with other GSK colleagues.
Ability to identify issues and independently devise and implement solutions.
Demonstrates an understanding of company priorities and responds appropriately and flexibly to ensure deadlines are met successfully.

Responsibilities

Responsible for the production (authoring or assisting the authors), in terms of quality and regulatory acceptability of manuscripts for new/revised prescribing information for products marketed in the US.
Identifies and resolves problems in a proactive manner.
Suggests creative approaches to capture labeling concepts in a succinct manner.
Ensures appropriate consistency in labeling documents across products for assigned area of responsibility.
Works with Labeling Strategy staff to ensure compliance with US Labeling processes.
Must be able to effectively articulate FDA and GSK requirements for labeling documents to GSK matrix teams, champion change, and recommend unique solutions, as needed.
Ensures all labeling regulatory requirements associated with assigned products are met.
Works with Matrix Team to resolve any labeling issues in a proactive manner.
Ensures accurate version control of multiple labeling submissions and components.
Develops FDA-compliant XML labeling documents for submission in accordance with GSK or FDA timelines.
Works with internal Drug Listing experts to coordinate Drug Listing submissions via XML labeling.
Produces all required versions of prescribing information documents for submission purposes and ensures all submission requirements are met for these documents.
Completes all assigned tasks to project deadlines.
Is able to manage own time at the task level and works on multiple projects in parallel.
Provides summaries of Labeling updates as needed for NDA or BLA Annual Reports.