Regulatory Submission Lead

Business Introduction
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.
Find out more:
Our approach to R&D

Position Summary
You will lead planning, compilation and delivery of regulatory submission dossiers for investigational and lifecycle activities in the United States. You will work closely with global submission teams, clinical, CMC, quality, publishing and local regulatory partners. We value organized, collaborative people who communicate clearly, solve problems practically, and focus on delivering high-quality submissions on time. This role offers visible impact on patient access, strong growth opportunities, and alignment with GSK’s mission of uniting science, technology and talent to get ahead of disease together.

Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Plan, compile and deliver complete regulatory submission dossiers (electronic and paper) on agreed timelines.

• Coordinate and track cross-functional inputs from clinical, CMC, quality, safety and commercial colleagues.

• Coordinate and manage Certificates of Pharmaceutical Product (CPPs), as well as notarization and legalization activities in support of global submissions.

• Build, validate and quality-check electronic submission packages and resolve technical validation issues.

• Maintain submission trackers, version control and milestone plans to ensure transparency and audit readiness.

• Draft and coordinate responses to regulatory authority questions and support regulatory meetings.

• Identify and implement process improvements, coach colleagues and share best practice.

Why You?

Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Bachelor’s degree in life sciences, pharmacy, chemistry, regulatory affairs or related discipline, or equivalent experience.

• 3+ years of experience in regulatory affairs, submission management, publishing or lifecycle maintenance within the pharmaceutical or clinical research environment.

• Experience compiling regulatory dossiers and managing submission timelines for investigational or marketed activities.

• Experience preparing electronic submissions and familiarity with eCTD principles or equivalent electronic submission practices.

• Experience interacting with Health Authorities, particularly the US FDA 

Preferred Qualification
If you have the following characteristics, it would be a plus:

• Experience with regulatory content or information management systems such as Veeva Vault or similar platforms.

• Experience with CMC content and Module 1 preparation for submissions.

• Knowledge of CPP processes and legalization/notarization requirements 

• Experience preparing responses to authority questions and supporting regulatory meetings.

• Experience working in a global, matrix environment and coordinating third-party vendors or vendors.

• Prior experience leading small project teams or serving as single point of contact for submissions.

• Professional certification in regulatory affairs or related field.

• Proven ability to manage third-party vendors and external partners 

• Strong written and verbal communication skills with the ability to present clear stakeholder updates.

• Strong organizational skills, attention to detail and proven ability to manage competing priorities under deadlines.

• Strong compliance mindset with high attention to detail 

• Experience working in a global, matrixed environment, with the ability to interpret complex regulatory requirements 

• Good digital proficiency

Work arrangement
This position is hybrid in the United States. Expect a mix of in-office days for team collaboration and remote days for focused work, as agreed with your manager.

#GSK-LI

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 purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - usrecruitment.adjustments@gsk.com

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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