Director, Precision Medicine Regulatory Strategy

GlaxoSmithKline; Upper Providence (Delaware County); Hybrid; USD 172,000 - 286,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive program

Health benefits

Job summary

GSK is seeking a senior Regulatory leader to shape regional Precision Medicine and Digital Health regulatory strategies across the portfolio. You will coordinate with global teams and senior stakeholders to ensure compliant, strategic execution.

Based in the United States with a hybrid work arrangement, the role requires collaboration with Health Authorities and cross-functional colleagues to drive development, submissions, and approvals, supported by an annual bonus and long-term incentive

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 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 strategy(s) and ensure timely delivery.
• Lead regulatory interactions and the review processes for GSK.
• Ensure regulatory compliance at all stages of product life from C2MD.
• Advocate persuasively to senior leaders in GSK and Health Authorities.
• Provide assessment of regulatory components leveraged for potential in-license molecules.

Skills

Regulatory strategy

Global regulatory submissions

Health Authority engagement

Cross-functional leadership

Excellent communication

Education

Bachelor's degree in biological or healthcare science

PhD in biological or healthcare science

Job description

GSK is seeking a senior Regulatory leader to shape regional Precision Medicine and Digital Health regulatory strategies across the portfolio. You will coordinate with global teams and senior stakeholders to ensure compliant, strategic execution.

Based in the United States with a hybrid work arrangement, the role requires collaboration with Health Authorities and cross-functional colleagues to drive development, submissions, and approvals, supported by an annual bonus and long-term incentive