Director, Regulatory Strategy – Precision Medicine

GlaxoSmithKline; Waltham (MA); Hybrid; USD 172,000 - 286,000; Full time

Benefits offered by this job

Health insurance

Retirement benefits

Paid holidays

Vacation

Parental leave

Medical leave

Job summary

GlaxoSmithKline is seeking a regulatory leader to develop and execute global strategies for Precision Medicine and Digital Health assets. The role focuses on aligning regional and global regulatory requirements, leading interactions with Health Authorities including the FDA, and ensuring compliant, timely labeling across the portfolio.

The position is hybrid and based in the United States, with responsibilities spanning multi-year planning and cross-functional matrix collaboration.

Qualifications

• Bachelor's degree in biological or healthcare science.
• 5+ years experience in regulatory consideration for all phases of the companion diagnostics and/or SaMD.
• Experience leading global development, submission and approval activities (FDA).
• Experience with clinical trial and licensing requirements for Precision Medicine and Digital Health Products in major countries.

Responsibilities

• Develop global Precision Medicine and Digital Health regulatory strategy and execution across GSK portfolio.
• Collaborate with regional/regulatory affiliates to create regional collaboration framework.
• Lead regulatory interactions and review processes for GSK.
• Ensure compliance with regulatory requirements at all stages of product life.

Skills

Business Resilience

Communication

Digital Fluency

Matrix Leadership

Pharmaceutical Regulatory Compliance

Regulatory Strategies

Resource Management

Stakeholder Management

Education

Bachelor's degree in biological or healthcare science

Job description

GlaxoSmithKline is seeking a regulatory leader to develop and execute global strategies for Precision Medicine and Digital Health assets. The role focuses on aligning regional and global regulatory requirements, leading interactions with Health Authorities including the FDA, and ensuring compliant, timely labeling across the portfolio.

The position is hybrid and based in the United States, with responsibilities spanning multi-year planning and cross-functional matrix collaboration.