Director, Global Regulatory Strategy

Location:

USA - Maryland - Rockville, USA - Pennsylvania - Upper Providence

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. This role will lead global regulatory strategy within a therapeutic area team in Global Regulatory Affairs, working 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.

• 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.

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

• 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.

• Advanced degree (MS, Pharm
  
  D, 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.

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.

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 work location, skills, experience, education level, and market rates. In addition, this position offers an annual bonus and eligibility to participate in our share‑based long‑term incentive program. 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.

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. For more details, please visit GSK US Benefits Summary.

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.