Director, Regulatory Affairs, Precision Medicine Digital Health

GSK • Rockville, MD

6d • $171,750 - $286,250 • Hybrid

About The Position

The Director, Regulatory Affairs, Precision Medicine and Digital Health is responsible for developing and executing appropriate regulatory strategies for assigned precision medicine and digital health assets across GSK’s therapeutic portfolio. The role ensures strategies are integrated with the overall global regulatory approach, comply with GSK processes and policies and regional regulatory requirements, and support the best possible labeling based on available data and global regulatory context.

The position plans across a multiple-year horizon and requires extensive matrix collaboration within GSK, including with senior leaders up to VP level, Precision Medicine and Digital Health teams, and regional regulatory affiliates. The role also contributes to establishing a regional collaboration framework for Precision Medicine and Digital Technologies. It is hybrid and based in the United States, with regular attendance at a GSK site for leadership meetings; candidates seeking remote work within the U.S. may be considered if they can travel as needed.

Requirements

• Bachelor’s degree in biological or healthcare science.
• At least 5 years of experience in regulatory considerations for all phases of companion diagnostics and/or Software as a Medical Device (SaMD), including projects with little or no precedent.
• Experience leading global development, submission, and approval activities with the FDA.
• Ability to organize and execute successful milestone meetings and a track record of successful relationships with one or more Health Authorities.
• Experience with clinical trial and licensing requirements for Precision Medicine and Digital Health products in major countries.
• Ability to work extensively across a matrix and engage senior stakeholders.

Nice To Haves

• PhD in a biological or healthcare science.
• Experience with Health Authorities outside the U.S. and EU.
• Sound knowledge of Precision Medicine and Digital Health clinical trial and licensing requirements globally.
• Excellent written and verbal communication skills, including the ability to communicate clearly and persuasively.
• Proven ability to foster matrix collaboration, facilitate groups in developing solutions, lead change, communicate difficult messages, and hold self and teams accountable for goals.
• Ability to build strong internal and external networks and secure project support and outcomes.
• Ability to recognize and resolve conflict, arbitrate when needed, and develop creative regulatory solutions while balancing agency expectations and compliance across regions.
• Ability to make sound decisions with incomplete information by weighing available information, benefits, and risks.

Responsibilities

• Develop and execute appropriate global and regional Precision Medicine and Digital Health regulatory strategies for assigned assets across GSK’s therapeutic portfolio.
• Lead regulatory interactions and GSK review processes.
• Ensure compliance with regulatory requirements throughout all stages of product life, from C2MD.
• Advocate approaches persuasively to senior GSK leaders and Health Authorities.
• Assess Precision Medicine and Digital Health components used in potential in-license molecules.
• Work extensively across GSK’s matrix, collaborate with Precision Medicine and Digital Health teams, and partner with regional regulatory affiliates to develop a regional collaboration framework.

Benefits

• Annual bonus
• Eligibility to participate in a share-based long-term incentive program, dependent on role level
• Health care and other insurance benefits for employees and families
• Retirement benefits
• Paid holidays
• Vacation
• Paid caregiver, parental, and medical leave

What This Job Offers

• Job Type: Full-time
• Career Level: Director