Director, Precision Medicine & Digital Health Regulation

GlaxoSmithKline; United States; Hybrid; USD 172,000 - 286,000; Full time

Benefits offered by this job

Annual bonus

Long term incentive program

Health insurance

Retirement benefits

Paid holidays, vacation and leave

Job summary

GlaxoSmithKline seeks a senior regulatory strategist to lead global regulatory strategies for Precision Medicine and Digital Health assets across the US portfolio. You will coordinate with global teams and drive regulatory success through life cycle stages.

Responsibilities include leading regulatory interactions, ensuring compliance, and advocating for optimal labeling across regions. This hybrid role requires collaboration with Health Authorities and cross-functional partners.

Qualifications

• 5+ years in regulatory consideration for companion diagnostics or SaMD.
• Experience leading global development, submission and FDA approvals.
• Proven ability to manage milestones and Health Authority relationships.
• Familiarity with clinical trial and licensing requirements for Precision Medicine and Digital Health.

Responsibilities

• Develop global regulatory strategy for Precision Medicine and Digital Health assets.
• Lead regulatory interactions and review processes for GSK.
• Ensure compliance with regulatory requirements across product life cycle.
• Collaborate with regional affiliates to create a regional collaboration framework.

Skills

Global regulatory experience

Regulatory strategy development

Leadership in regulatory programs

Stakeholder management

Education

Bachelor's degree in biological or healthcare science

Job description

GlaxoSmithKline seeks a senior regulatory strategist to lead global regulatory strategies for Precision Medicine and Digital Health assets across the US portfolio. You will coordinate with global teams and drive regulatory success through life cycle stages.

Responsibilities include leading regulatory interactions, ensuring compliance, and advocating for optimal labeling across regions. This hybrid role requires collaboration with Health Authorities and cross-functional partners.