Director, Global Regulatory Strategy
GSK, Collegeville, PA, United States
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. 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 the 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: two to three days on‑site per week.
Basic Qualifications
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 Qualifications
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.
Compensation and Benefits Salary ranges for this role vary by location: $171,600 to $286,000 (annual base). The position offers an annual bonus and eligibility for a share‑based long‑term incentive program. Benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.
Equal Opportunity Employer 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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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 the 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: two to three days on‑site per week.
Basic Qualifications
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 Qualifications
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.
Compensation and Benefits Salary ranges for this role vary by location: $171,600 to $286,000 (annual base). The position offers an annual bonus and eligibility for a share‑based long‑term incentive program. Benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.
Equal Opportunity Employer 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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