Director, Regulatory Affairs - Vaccines

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 regulatory process improvements and support regulatory activities across the United States. You will work closely with cross-functional teams, external partners, and senior leaders to simplify processes, reduce cycle times, and improve quality. We value curiosity, clear communication, and a practical approach to problem solving. This role offers growth, visible impact, and the chance to help GSK unite science, technology and talent to get ahead of disease together.

Key Responsibilities

Accountable to GRL and Global Regulatory TA Head for development of appropriate regional and/or global

regulatory strategy(ies) and for delivery according to plans. The Regulatory Director may be the single point of contact on assigned asset(s), responsible for regional and global regulatory strategy(ies). In conducting role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK to VP level and representing GSK with at least the local regulatory agency. Work closely with local / regional commercial team to secure best possible labelling commensurate with the available data. Lead interactions with local / regional regulatory authorities.

• Ensure the regulatory strategy will deliver the needs of the local region(s), taking in to account the needs of other regions globally
• Implement the regional strategy(s) in support of the project globally
• Lead regulatory interactions and the review processes in local region
• Ensure appropriate interaction with regional commercial teams in local region
• Ensure compliance with regional requirements at all stages of product life from C2MD
• Ideally able to advocate persuasively approaches to senior leaders in GSK and in Health Authorities
• Capable of providing assessment of potential in license molecules

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 Biological or Healthcare Science, with previous experience in similar strategic international regulatory affairs positions.

• Extensive Experience (5+ years) in regulatory affairs across all phases of drug development.

• Proven track record in leading regional development, submission, and approval activities.

• Experience working on clinical trial and licensing requirements in major countries.

• Experience in Vaccines Regulatory Affairs

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

• PhD in Biological or Healthcare Science.

• Expertise in developing product or therapeutic knowledge in new areas.

• Familiarity with digitalization in regulatory strategy to enhance decision-making and innovation.

• Proven ability to deliver creative solutions to regulatory challenges while ensuring compliance.

• Exceptional communication and leadership skills, with the ability to build strong networks and influence stakeholders.

Work Arrangement
This position is hybrid with a requirement for regular on-site collaboration. Minimum 2-3 days a week onsite.

What we value
We welcome people who bring different perspectives and life experiences. We foster an inclusive environment where you can be yourself, learn, and grow. You will join a team that values transparency, teamwork, and practical progress. If you want to help make medicines and processes better for patients while building your regulatory career, we encourage you to apply.

Apply now and tell us how your experience will help improve regulatory outcomes and drive meaningful change.

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.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at HR.AmericasSC-CS@gsk.com where you can also request a call.

Please note should your inquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive

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/