Director, Regulatory Strategy: Precision Medicine & Digital Health

GlaxoSmithKline; Rockville (MD); Hybrid; USD 172,000 - 286,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive program

Health care and other insurance

Job summary

GlaxoSmithKline in the United States is seeking a senior Regulatory Strategy leader for Precision Medicine and Digital Health. You will drive regional regulatory strategies across the portfolio and lead interactions with Health Authorities to secure timely approvals.

The role requires extensive matrix leadership, collaboration with global teams, and a proven track record in navigating regulatory pathways and licensing across major markets. This position is hybrid in the US with travel as needed.

Qualifications

• Bachelor's degree in biological or healthcare science.
• 5+ years experience in regulatory consideration for companion diagnostics and/or SaMD.
• Experience of leading global development, submission and approval activities (FDA).
• Experience with Health Authority relationships, including ex US and EU preferred.
• Experience with clinical trial and licensing requirements for Precision Medicine and Digital Health.

Responsibilities

• Develop regional regulatory strategies for Precision Medicine and Digital Health across the GSK portfolio.
• Lead regulatory interactions and review processes for GSK.
• Ensure regulatory compliance at all stages of product life from C2MD.
• Collaborate with regional regulatory affiliates to create a regional collaboration framework for Precision Medicine & Digital Technologies.

Skills

Regulatory strategy

Global regulatory experience

Health Authority liaison

Project management

Communication skills

Education

Bachelor's degree in biological or healthcare science

PhD in biological or healthcare science

Job description

GlaxoSmithKline in the United States is seeking a senior Regulatory Strategy leader for Precision Medicine and Digital Health. You will drive regional regulatory strategies across the portfolio and lead interactions with Health Authorities to secure timely approvals.

The role requires extensive matrix leadership, collaboration with global teams, and a proven track record in navigating regulatory pathways and licensing across major markets. This position is hybrid in the US with travel as needed.