Associate Director, GRA Precision Medicine & Digital Health

GlaxoSmithKline - Collegeville, PA

Full-time - Mid Level

Collegeville, PA

5,001-10,000 employees

Chemical Manufacturing

About the position

The Associate Director of GRA Precision Medicine & Digital Health at GSK is responsible for developing and executing regulatory strategies for precision medicine and digital health assets across the GSK therapeutic portfolio. This role involves extensive collaboration with various teams and regulatory authorities to ensure compliance with internal processes and regional requirements, ultimately aiming to deliver optimal product labeling and support the company's global regulatory approach.

Responsibilities

• Develop and execute global Precision Medicine and Digital Health regulatory strategies for assigned assets.
• Lead regulatory interactions and review processes for GSK.
• Ensure compliance with regulatory requirements throughout the product life cycle.
• Advocate for regulatory approaches to senior leaders and health authorities.
• Assess Precision Medicine and Digital Health components for potential in-license molecules.
• Build and maintain the team's book of work, ensuring timely delivery of strategies.

Requirements

• BS in biological science, healthcare science, or engineering.
• Minimum of 1 year experience in regulation of in vitro diagnostics, companion diagnostics, and/or SaMD within a pharmaceutical company in at least one major market.
• Minimum of 1 year experience with clinical trial and licensing requirements for Precision Medicine and Digital Health Products in at least one major market.

Nice-to-haves

• MS or PhD in a biological science, healthcare science, or engineering.
• Experience leading global development, submission, and approval activities.
• Organized and executed milestone meetings with Health Authorities.
• Excellent communication skills, both written and verbal.
• Proven ability to foster strong matrix working and facilitate group collaboration.

Benefits

• Comprehensive benefits program including health insurance, retirement plans, and wellness programs.