Regulatory affairs associate Jobs in Durham, NC

The Regulatory Affairs Associate provides support to GRA US Labeling staff and Regulatory Matrix Teams to ensure the timely updates and management of quality US Product Information (PI) / labeling and supporting documentation. The Regulatory Affairs Associate ensures effective coordination, communication, and maintenance of US labeling documents and data in regulatory systems in accordance with defined standards and processes.

Job 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.

1. Provision of Regulatory advice regarding prescribing information requirements to a range of development projects and more broadly across the Global Regulatory Affairs and GSK Matrix Teams.

2. Ensuring prescribing information for prescription products in the US meet all regulatory requirements.

3. Production of FDA-compliant XML labeling documents.

4. Ensuring proper version control of US prescribing information.

This role does not require management of staff. Some training or mentoring of staff may be required.

Demonstrates an understanding of regulatory labeling requirements for US prescribing information submissions, and a detailed understanding of internal policies, procedures, and guidelines. Uses this knowledge to initiate or provide input into the authoring of prescribing information, and to produce all required labeling documents for US submissions.

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.

Is considered an authoritative source for FDA and GSK requirements for prescribing information, including XML labeling.

Demonstrates an understanding of company priorities and responds appropriately and flexibly to ensure deadlines are met successfully.

Basic Qualifications :

Bachelor’s Degree required.

1+ years Labeling and regulatory experience in the pharmaceutical industry.

Preferred Qualifications :

Degree in Science or Life Science area preferred.

Knowledge of FDA regulations relevant to labeling and XML labeling.

Proficient with computer software applications and medical terminology.

Ability to negotiate solutions to labeling issues.

Experience working on multiple projects with attention to detail.

Please visit to learn more about the comprehensive benefits program GSK offers US employees.

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GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory / immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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