Director, Regulatory Affairs - Vaccines

Overview

Position:
Regulatory Director – US Regulatory Affairs

At GSK, we aim to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on vaccines and medicines, combining our understanding of the immune system with technology to transform lives. We seek to unite science, technology and talent to get ahead of disease together.

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. This role offers growth, visible impact, and the chance to help GSK unite science, technology and talent to get ahead of disease together.

• 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).
• Plan on a multiple-year horizon and collaborate extensively within GSK to VP level, representing GSK with local regulatory agencies.
• Work closely with local/regional commercial teams to secure the best possible labeling data.
• Lead interactions with local/regional regulatory authorities.
• Ensure the regulatory strategy delivers the needs of the local region while considering global/regional needs.
• Implement regional strategies in support of the project globally.
• Lead regulatory interactions and review processes in the local region.
• Ensure appropriate interaction with regional commercial teams.
• Ensure compliance with regional requirements at all stages of product life from C2MD.
• Advocate persuasively to senior leaders in GSK and Health Authorities when appropriate.
• Provide assessment of potential in-license molecules.

Basic Qualification

• Bachelor's degree in Biological or Healthcare Science with experience in international regulatory affairs.
• 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

• 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 ability to build networks and influence stakeholders.

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

We value diverse perspectives and life experiences. We foster an inclusive environment where you can learn, grow, and contribute. We seek teamwork, transparency 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.

Salary and Benefits

If based in Cambridge, MA;
Waltham, MA;
Rockville, MD; or San Francisco, CA, the annual base salary for new hires ranges $171,600 to $286,000, with possible annual bonus and eligibility for long-term incentive programs. Benefits include health care and other insurance for employee and family, retirement benefits, paid holidays, vacation, and caregiver/parental and medical leave. If salary ranges are not displayed, compensation will be discussed in the recruitment process.

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

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 health and operate across four therapeutic areas: respiratory/immunology, oncology, HIV, and infectious diseases. We are committed to an inclusive environment where our people can thrive and contribute to patients and shareholders.

If you require adjustments to demonstrate strengths, contact  to request a call or more information. For other questions, refer to our Recruitment FAQ guide.

GSK is an Equal Opportunity Employer. This ensures equal consideration regardless of race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information, military service, or any basis prohibited by law.

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