Director, Regulatory Affairs, Precision Medicine Digital Health

GSK • Waltham, MA

4d • Hybrid

About The Position

The Director, Regulatory Affairs, Precision Medicine Digital Health ensures the development and execution of appropriate global and regional regulatory strategies for assigned precision medicine and digital health assets across GSK’s therapeutic portfolio. The role supports regulatory strategies both as part of the overall global regulatory approach and in compliance with GSK processes and policies and regional regulatory requirements, with the aim of delivering the best possible labeling based on available data and global regulatory context.

The position is accountable to the GRL and Global Regulatory Science Precision Medicine Head. It requires planning over a multiple-year horizon and extensive matrix collaboration within GSK, including work with Precision Medicine and Digital Health teams and regional regulatory affiliates. The role also contributes to developing a regional collaboration framework for Precision Medicine and Digital Technologies. The Director leads regulatory interactions and review processes, ensures compliance throughout the product lifecycle, advocates approaches to senior GSK leaders and Health Authorities, and assesses Precision Medicine and Digital Health components for potential in-license molecules.

The role is hybrid and based in the United States, with regular attendance at a GSK site for leadership meetings. Candidates open to remote work within the U.S. may be considered if they can travel as needed. The annual base salary range is $171,750 to $286,250, depending on location and other factors. The position also offers an annual bonus and eligibility for a share-based long-term incentive program, depending on role level.

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.
• 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, and ideally sound knowledge of requirements globally.

Nice To Haves

• PhD in a biological or healthcare science.
• Experience with Health Authorities outside the United States and European Union.
• Excellent written and verbal communication skills, with the ability to communicate clearly, compellingly, and with impact.
• Ability to foster strong matrix working and facilitate groups in developing solutions.
• Ability to lead change and communicate difficult messages.
• Ability to implement plans and hold oneself and teams accountable for short- and medium-term goals.
• Ability to build and use strong internal and external networks to secure project support and outcomes.
• Ability to proactively recognize and resolve conflict and arbitrate as needed.
• Ability to develop creative regulatory solutions while balancing agency expectations and regulatory compliance across regions.
• Ability to seek information broadly to understand the wider context.
• Ability to make sound decisions with incomplete information or under time constraints, weighing available information, benefits, and risks.

Responsibilities

• Develop and deliver appropriate regional and global Precision Medicine and Digital Health regulatory strategies for assigned assets across GSK’s therapeutic portfolio.
• Plan regulatory strategy and delivery on a multiple-year horizon, working extensively across the GSK matrix, including with senior leaders up to VP level.
• Work closely with Precision Medicine and Digital Health teams and regional regulatory affiliates, including contributing to a regional collaboration framework for Precision Medicine and Digital Technologies.
• Lead regulatory interactions and GSK review processes.
• Ensure compliance with regulatory requirements throughout the product lifecycle, from C2MD.
• Advocate regulatory approaches persuasively to senior GSK leaders and Health Authorities.
• Assess Precision Medicine and Digital Health components leveraged for potential in-license molecules.

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 family
• Retirement benefits
• Paid holidays
• Vacation
• Paid caregiver, parental, and medical leave

What This Job Offers

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