Regulatory Strategy Director, Precision Medicine

GlaxoSmithKline; Durham (NC); Hybrid; USD 172,000 - 286,000; Full time

Benefits offered by this job

Health care and other insurance

Retirement benefits

Paid holidays

Vacation

Paid caregiver/parental and medical/

Job summary

GSK in the United States is seeking a senior regulatory professional to develop and execute regulatory strategies for precision medicine and digital health assets across the therapeutic portfolio. This hybrid role includes leadership of regional regulatory plans, coordination with global teams, and regular interactions with health authorities to secure timely submissions and approvals.

Candidates should have 5+ years of global regulatory experience, a biology/healthcare degree (PhD preferred),

Qualifications

• Bachelor's degree in biological or healthcare science.
• 5+ years experience in regulatory consideration for all phases of companion diagnostics and/or SaMD.
• Experience leading global development, submission and approval activities (FDA).
• Ability to advocate persuasively to senior leaders and health authorities.
• Experience with clinical trial and licensing requirements for precision medicine and digital health products.

Responsibilities

• Develop global regulatory strategy(s) for Precision Medicine and Digital Health assets across the portfolio.
• Lead regulatory interactions and review processes for GSK.
• Ensure compliance with regulatory requirements at all stages of product life from C2MD.
• Collaborate with regional affiliates to create regional collaboration frameworks.

Skills

Regulatory leadership

Global regulatory experience

Cross-functional collaboration

Communication skills

Strategic planning

Education

Bachelor's degree in biological or healthcare science

Job description

GSK in the United States is seeking a senior regulatory professional to develop and execute regulatory strategies for precision medicine and digital health assets across the therapeutic portfolio. This hybrid role includes leadership of regional regulatory plans, coordination with global teams, and regular interactions with health authorities to secure timely submissions and approvals.

Candidates should have 5+ years of global regulatory experience, a biology/healthcare degree (PhD preferred),