Regulatory Strategy Director – Precision Medicine

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

Job summary

GSK in the United States seeks a leader to develop and execute regulatory strategies for Precision Medicine and Digital Health assets across the portfolio. You will coordinate global regulatory activities, interact with health authorities, and guide cross-functional teams through development, submission, and approval processes.

You will partner with regional affiliates, advise senior leaders, and ensure compliance from early development to lifecycle management.

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, including for projects with little or no precedence.
• Experience of leading global development, submission and approval activities (FDA).
• Capable of organizing and executing successful milestone meetings and with track record of successful relationship with one or more Health Authority, additional experience ex US and EU preferred.
• Experience with clinical trial and licensing requirements for Precision Medicine and Digital Health Products in major countries and ideally sound knowledge globally.

Responsibilities

• Develop regional Precision Medicine and Digital Health regulatory strategies and ensure timely delivery.
• Lead regulatory interactions and review processes for GSK; ensure compliance across product life cycle.
• Collaborate with regional affiliates to build regional collaboration framework for Precision Medicine & Digital Technologies.
• Advocate persuasively to senior leaders and health authorities.

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

PhD in a biological or healthcare science

Job description

GSK in the United States seeks a leader to develop and execute regulatory strategies for Precision Medicine and Digital Health assets across the portfolio. You will coordinate global regulatory activities, interact with health authorities, and guide cross-functional teams through development, submission, and approval processes.

You will partner with regional affiliates, advise senior leaders, and ensure compliance from early development to lifecycle management.