Regulatory Associate - US Country Labeling

Are you looking for a role where you can showcase your labeling skills? If so, this is the job for you.

As Regulatory Associate, you will:

• 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.
• Identify and resolve problems in a proactive manner.
• Suggest creative approaches to capture labeling concepts in a succinct manner.
• Ensure appropriate consistency in labeling documents across products for assigned area of responsibility.
• Work with Labeling Strategy staff to ensure compliance with US Labeling processes.
• Effectively articulate FDA and GSK requirements for labeling documents to GSK matrix teams, champion change, and recommend unique solutions, as needed.
• Ensure all labeling regulatory requirements associated with assigned products are met.
• Work with Matrix Team to resolve any labeling issues in a proactive manner.
• Ensure accurate version control of multiple labeling submissions and components.
• Develop FDA-compliant XML labeling documents for submission in accordance with GSK or FDA timelines.
• Work with internal Drug Listing experts to coordinate Drug Listing submissions via XML labeling.
• Produce all required versions of prescribing information documents for submission purposes and ensures all submission requirements are met for these documents.
• Complete all assigned tasks to project deadlines.
• Manage own time at the task level and work on multiple projects in parallel.
• Provide summaries of Labeling updates as needed for NDA or BLA Annual Reports.
• The major outputs of this position are:

• 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.

• Demonstrate an understanding of regulatory labeling requirements for US prescribing information submissions, and a detailed understanding of internal policies, procedures, and guidelines. Initiate or provide input into the authoring of prescribing information, and to produce all required labeling documents for US submissions.
• Work with project teams to resolve issues regarding prescribing information requirements.
• Build positive relationships within Labeling team and with other GSK colleagues.
• Identify issues and independently devise and implement solutions.
• Responsible and authoritative source for FDA and GSK requirements for prescribing information, including XML labeling.
• Understanding of company priorities and responds appropriately and flexibly to ensure deadlines are met successfully.

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

Basic Qualifications:

• Bachelor's Degree in a Science or Life Science area
• 2+ years experience with medical terminology
• 2+ years experience with Labeling and Regulatory as well as FDA regulations relevant to labeling.
• 2+ years experience with M/S office software applications.

Preferred Qualifications:

• Knowledge of XML labeling, preferred.
• Experience negotiating solutions to labeling issues as well as working on multiple projects with attention to detail.
• Proficient written and oral communication skills.

#LI-GSK

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

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

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.

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