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 registration requirements for investigational and lifecycle activities globally. 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 registration requirements for submission dossiers (electronic and paper) on agreed timelines.

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

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

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

• 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 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 Labeling, CMC content and Module 1 preparation for submissions.

• Knowledge of CPP processes and legalization/notarization requirements 

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

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

• Experience working in a global, matrix environment and coordinating third-party vendors or vendors, with the ability to interpret complex regulatory.

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

• Professional certification in regulatory affairs, Notary 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 

• 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 - [email protected]

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.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/