Director, Global Regulatory Strategy

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.

Position Summary

You will lead global regulatory strategy within a therapeutic area team in Global Regulatory Affairs. You will work with cross-functional colleagues across development, safety, medical, and commercial teams. You will shape regulatory approaches that enable timely access to medicines while meeting high quality standards. We value clear communicators who build trust, make evidence-based decisions, and grow others. This role offers visible impact, professional growth, and the chance to unite science, technology and talent to get ahead of disease together.

Responsibilities

Lead development and execution of regulatory strategy for assigned therapeutic assets across global regions.

Coordinate and represent the therapeutic group in cross-functional development and regulatory governance forums.

Manage regulatory interactions with health authorities and support advocacy to influence evolving requirements.

Ensure regulatory compliance across product lifecycle.

Support resource planning, budgeting, and team capability development within the therapeutic regulatory group.

Drive continuous improvement of regulatory processes and metrics to reduce cycle time and improve quality.

Work arrangement

This role is hybrid. Regular on-site collaboration is expected. Typical schedule will be two to three days on-site per week.

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, medicine, or a related field.

• At least 8 years of regulatory affairs experience in the pharmaceutical or biotech industry.
• Experience leading a successful NDA or BLA submission
• Experience leading or managing matrixed teams across regions or functions.
• Experience with health authorities including the FDA and supporting regulatory interactions.
• Experience of stakeholder engagement and cross-functional collaboration

Preferred Qualification

• Advanced degree (MS, PharmD, MD, or PhD) in a relevant scientific discipline.
• Experience with international health agencies such as the EMA
• Proven track record leading global or regional submission strategies and approvals.
• Experience building regulatory policy or advocacy positions with health authorities.
• Familiarity with digital tools or approaches applied to regulatory strategy and operations.
• Demonstrated ability to develop people, build capability, and lead change.

What we value in you

You are collaborative, curious, and accountable. You make clear recommendations and balance scientific, regulatory, and commercial considerations. You build trusted relationships and help create an inclusive environment where everyone can do their best work. We welcome people with diverse perspectives and life experience. If you want to help shape regulatory strategy and improve outcomes for patients, we encourage you to apply.

• If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $171,600 to $286,000. The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.

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.

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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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