Director, Regulatory Affairs, Precision Medicine & Digital Health

GSK • Rockville, MD

2d • Onsite

About The Position

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together. Find out more: Our approach to R&D Position Summary You will lead regulatory strategy for precision medicine and digital health across respective regions. You will work with scientific, clinical, digital and commercial teams to design and deliver regulatory plans that enable safe, effective and compliant development. We value strategic thinking, clear communication, and collaborative leadership. This role offers visible impact, career growth, and the chance to help unite science, technology and talent to get ahead of disease together. Please note: This position requires an on-site office -based presence 2 to 3 days a week in the US (MA, MD, PA or NC); UK (London or Stevenage); or Poland (Warsaw) office.

Requirements

• Bachelor’s degree in biological science, healthcare science, engineering or equivalent.
• Experience working in the pharmaceutical industry, MedTech industry or regulating authorities
• Practical experience with regulation of companion diagnostics and/or SaMD.
• Proven track record leading development, submission and approval activities in one or more regions.
• Experience preparing for and leading regulatory milestone meetings and authority interactions.
• Strong written and verbal communication skills and ability to work in a matrix environment.

Nice To Haves

• Advanced degree (MSc, MS, PhD, MD or equivalent) in a relevant discipline.
• Deep knowledge of clinical trial and licensing requirements for precision medicine and digital health across major markets.
• Experience influencing senior stakeholders and advocating regulatory positions.
• Proven ability to build strong cross-functional networks and external relationships.
• Practical experience assessing in-licensing opportunities involving diagnostic or digital components.
• Experience coaching or developing junior regulatory professionals.

Responsibilities

• Lead development and execution of regional regulatory strategies for precision medicine and digital health assets.
• Coordinate regulatory interactions with local and regional health authorities and external partners.
• Provide regulatory input to cross-functional project teams from early development through lifecycle management.
• Ensure regulatory compliance for companion diagnostics, software as a medical device (SaMD), and digital health components.
• Interpret regulatory feedback and translate it into clear operational plans and submission materials.
• Mentor and coach colleagues to build regulatory capability across the business.

What This Job Offers

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