Director, Global Regulatory Strategy
GSK
6 hours ago
Remote friendly (Collegeville, PA)
United States
Corporate Functions
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.
- Drive continuous improvement of regulatory processes and metrics to reduce cycle time and improve quality.
Work arrangement:
- Hybrid; typically 2–3 days per week on-site.
Required qualifications/skills:
- Bachelor’s degree in life sciences, pharmacy, medicine, or related field.
- 8+ years of regulatory affairs experience in pharma/biotech.
- Experience leading a successful NDA or BLA submission.
- Experience leading/managing matrixed teams across regions or functions.
- Experience with health authorities (including FDA).
- Stakeholder engagement and cross-functional collaboration experience.
Preferred qualifications:
- Advanced degree (MS, PharmD, MD, or PhD).
- Experience with international agencies (e.g., EMA).
- Track record leading global/regional submission strategies and approvals.
- Experience building regulatory policy/advocacy positions.
- Familiarity with digital tools/approaches for regulatory strategy/operations.
- Demonstrated ability to develop people and lead change.
Benefits/compensation (if stated):
- Annual base salary (new hires) ranges $171,600–$286,000 (location-dependent); annual bonus; share-based long-term incentive eligibility; health care/insurance, retirement, paid holidays, vacation, and paid caregiver/parental and medical leave.
- 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.
- Drive continuous improvement of regulatory processes and metrics to reduce cycle time and improve quality.
Work arrangement:
- Hybrid; typically 2–3 days per week on-site.
Required qualifications/skills:
- Bachelor’s degree in life sciences, pharmacy, medicine, or related field.
- 8+ years of regulatory affairs experience in pharma/biotech.
- Experience leading a successful NDA or BLA submission.
- Experience leading/managing matrixed teams across regions or functions.
- Experience with health authorities (including FDA).
- Stakeholder engagement and cross-functional collaboration experience.
Preferred qualifications:
- Advanced degree (MS, PharmD, MD, or PhD).
- Experience with international agencies (e.g., EMA).
- Track record leading global/regional submission strategies and approvals.
- Experience building regulatory policy/advocacy positions.
- Familiarity with digital tools/approaches for regulatory strategy/operations.
- Demonstrated ability to develop people and lead change.
Benefits/compensation (if stated):
- Annual base salary (new hires) ranges $171,600–$286,000 (location-dependent); annual bonus; share-based long-term incentive eligibility; health care/insurance, retirement, paid holidays, vacation, and paid caregiver/parental and medical leave.