Director, Regulatory Affairs, Precision Medicine & Digital Health

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.
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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.

Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

- 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.

Why You?

Basic Qualifications
We are seeking professionals with the following required skills and qualifications to help us achieve our goals

- 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.

Preferred Qualifications
If you have the following characteristics, it would be a plus

- 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.

What we offer in your development
You will have opportunities to lead high-visibility projects and grow your regulatory leadership skills. You will work with multidisciplinary teams and external partners to shape how new technologies reach patients. Your work will directly support GSK’s mission to unite science, technology and talent to get ahead of disease together.

How to apply
If you are ready to shape regulatory strategy for precision medicine and digital health, we want to hear from you. Please submit your CV and a short cover letter that explains how your experience matches this role. We welcome applications from all backgrounds and encourage people who may not meet every single criterion to apply.

• If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $171,750 to $286,250. The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.The annual base salary in Poland for new hires in this position ranges from PLN 0 to PLN 0 gross, taking into account a number of factors including the candidate’s skills, experience, education level and the market rate for the role. Depending on the role and internal policies, the position may also be eligible for a bonus (if applicable and based on defined, non-discretionary criteria) and/or awards for exceptional performance (granted at the employer’s discretion). All statutory benefits will be maintained in accordance with Polish law. Other benefits may also be offered, which may include private healthcare, additional paid days off, life insurance, private pension plan and fully paid parental leave & care of family member leave. More detailed information on the total reward package applicable to your role will be supplied during the recruitment process. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the market rate for the role.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

 

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

 

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

 

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

 

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

 

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at UKRecruitment.Adjustments@gsk.com where you can also request a call.

 

Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a  Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive

 

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