Director, Global Regulatory Strategy
GSK
4 hours ago
Remote friendly (Rockville, MD)
United States
Corporate Functions
Position Summary:
- Lead global regulatory strategy within a therapeutic area team in Global Regulatory Affairs. Partner with cross-functional colleagues across development, safety, medical, and commercial teams to shape regulatory approaches that enable timely access to medicines while meeting high quality standards.
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:
- Hybrid; typically two to three days on-site per week.
Basic Qualification (Required):
- 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 with 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/approaches applied to regulatory strategy and operations.
- Demonstrated ability to develop people, build capability, and lead change.
- Lead global regulatory strategy within a therapeutic area team in Global Regulatory Affairs. Partner with cross-functional colleagues across development, safety, medical, and commercial teams to shape regulatory approaches that enable timely access to medicines while meeting high quality standards.
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:
- Hybrid; typically two to three days on-site per week.
Basic Qualification (Required):
- 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 with 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/approaches applied to regulatory strategy and operations.
- Demonstrated ability to develop people, build capability, and lead change.