Director, Global Regulatory Strategy

GSK • Rockville, MD

1d • Hybrid

About The Position

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.

Requirements

• 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

Nice To Haves

• 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.

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.

Benefits

• 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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director