New · posted Nov 6
GSK · Pharmaceuticals
Director, Regulatory Affairs, Precision Medicine Digital Health
- Waltham, MA
- Hybrid
- Full-time
- Director
The role
Ensure the development of appropriate Precision Medicine and Digital Health regulatory strategy(s) and their execution for assigned precision medicine and digital health asset(s) supporting across the GSK therapeutic portfolio. This goal must be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process and policy and with regional regulatory requirements to deliver the best possible labeling, commensurate with the available data and in the global regulatory context.
Business Introduction
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
What you need
We are looking for professionals with these required skills to achieve our goals
- Bachelor’s degree in biological or healthcare science.
- 5+ years experience in regulatory consideration for all phases of the companion diagnostics and/or SaMD, including for projects with little or no precedence.
- Experience of leading global development, submission and approval activities (FDA).
- Capable of organizing and executing successful milestone meetings and with track record of successful relationship with one or more Health Authority, additional experience ex US and EU preferred.
- Experience with clinical trial and licensing requirements for Precision Medicine and Digital Health Products in major countries and ideally sound knowledge globally.
Responsibilities and Accountabilities
Accountable to GRL and Global Regulatory Science Precision Medicine Head for development of appropriate regional Precision Medicine and Digital Health regulatory strategy(s) and their timely delivery. In this role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK to VP level. This role works closely with members of the Precision Medicine and Digital Health teams. This role will also have significant collaboration with the regional regulatory affiliates in the creation of a regional collaboration framework for Precision Medicine & Digital Technologies.
In performing the role, the job holder will be responsible for:
- Ensure the development of appropriate global Precision Medicine and Digital Health regulatory strategy(s) and their execution for assigned precision medicine and digital health asset(s) supporting across the GSK therapeutic portfolio. Leading regulatory interactions and the review processes for GSK.
- Ensuring compliance with regulatory requirements at all stages of product life from C2MD.
- Ideally able to advocate persuasively approaches to senior leaders in GSK and in Health Authorities.
- Capable of providing assessment of Precision Medicine and Digital Health components leveraged for potential in-license molecules.
Business Resilience, Communication, Digital Fluency, Matrix Leadership, Pharmaceutical Regulatory Compliance, Regulatory Strategies, Resource Management, Stakeholder Management• 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. • If you are based in another US location, the annual base salary range is $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.
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
If you have the following characteristics, it would be a plusnice to have
- PhD in a biological or healthcare science.
- Excellent communication skills, ideally in writing and verbally. Proven ability to deliver key communication with clarity, impact and passion. Commands attention and interest through use of appropriate communication techniques. Proven ability to foster strong matrix working. Capable of facilitating groups of individuals to work together on creating solutions. Ability to lead change and communicate difficult messages. Able to implement plans and hold self and team accountable for delivery of short and medium term goals.
- Proven ability to build strong personal networks, within GSK and use them to secure appropriate support and outcome for a project, developing an external network.
- Ability to proactively recognize and resolve conflict and arbitrate as necessary, seeking help as necessary to ensure successful outcome. Proven ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulation in all regions. Will seek information from a broad range of sources, within and outside the normal range of enquiry to understand wider context.
Proven ability to take sound decisions, often without complete information, or in situations where consultation with others is not possible due to situation or time constraints. In doing so, the job holder will use all available sources of information and weight benefits and risks before making important decisions.
Work Arrangement
This role is hybrid, based in the United States. Regular attendance at a GSK site for leadership meetings is expected. Candidates open to remote work within the U.S. may be considered if they can travel as needed.
Ready to advance your career while helping bring breakthrough digital health and precision medicine solutions to patients worldwide? Apply now and be part of an inclusive team where your expertise makes a real difference. Join GSK and help us get ahead of disease together.
Pay and benefits
$171,750 – $286,250 a year
Employer providedAnnual bonus
Long-term incentive program
Health care and insurance benefits
Retirement benefits
Paid holidays and vacation
Paid caregiver/parental and medical leave
Where you'll work
Waltham, MAHybridOpen in Maps (opens in a new tab)
More jobs in Waltham, MA
From the posting
About GSK
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.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - [email protected]
Equal opportunity, accessibility and legal noticesGSK's statements, word for word
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/
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.
Job intelligence
The context around this role
Live data · November 6, 2026
Salary intelligence
How the pay compares
This role's midpoint is 9% below the US median for Regulatory Strategy roles at this level.
This roleEmployer provided
Director roles in Massachusetts15 roles publishing pay
Director roles in the US46 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $171,750 | — | $286,250 |
| Massachusetts (middle half) | $228,250 | $264,000 | $275,000 |
| All US (middle half) | $227,500 | $252,000 | $268,875 |
This role: GSK's own published range. Comparisons: the base pay employers published on open Regulatory Strategy roles at the same level on Regulatory Jobs, November 6, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Strategy
The general path across 89 open Regulatory Strategy roles on Regulatory Jobs, with the titles they carry most. Not GSK's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 21 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Regulatory submissions6
- Collaboration and leadership5
- GMP and compliance4
- Documentation and SOPs2
- Clinical trial conduct1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Regulatory Strategy work in pharmaceuticals, each linked to the agency or standards body that publishes it.
- FDAFDA expedited programs(official source, opens in a new tab)Fast track, breakthrough therapy, accelerated approval and priority review
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trials
- FDA21 CFR Part 314(official source, opens in a new tab)Applications for FDA approval to market a new drug (NDA and ANDA)
- EUDirective 2001/83/EC(official source, opens in a new tab)The EU code for medicinal products for human use: authorization, labeling, pharmacovigilance
- FDA21 CFR Part 201(official source, opens in a new tab)FDA labeling requirements for drugs, including prescribing information
- ICHICH M4 (CTD)(official source, opens in a new tab)The Common Technical Document: how a registration dossier is organized
- ICHICH E8(R1)(official source, opens in a new tab)General considerations for clinical studies and quality by design in trials
- ICHICH E9 and E9(R1)(official source, opens in a new tab)Statistical principles for clinical trials and estimands
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trials
- EUEU Clinical Trials Regulation 536/2014(official source, opens in a new tab)How clinical trials of medicines are authorized and run in the EU, through CTIS
- FDA21 CFR 314.70(official source, opens in a new tab)Supplements and other changes to an approved application (post-approval CMC changes)
- EURegulation (EC) 1234/2008(official source, opens in a new tab)EU variations to the terms of a marketing authorization
- PMDAJapan PMDA(official source, opens in a new tab)Japan's Pharmaceuticals and Medical Devices Agency
- MHRAUK MHRA(official source, opens in a new tab)The UK regulator of medicines and medical devices, including UKCA marking
- Health CanadaCanada Food and Drug Regulations(official source, opens in a new tab)Health Canada's regulations for drugs, including GMP (Part C, Division 2)
- FDAFDA REMS(official source, opens in a new tab)Risk Evaluation and Mitigation Strategies for drugs with serious safety concerns
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
GSK on Regulatory Jobs
- 36
- Open roles
- 36
- Distinct roles
- 7
- Locations
By discipline
- Clinical19 53%
- Quality13 36%
- Regulatory4 11%
By level
- Director19 53%
- Associate & Specialist8 22%
- Manager4 11%
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Director, Regulatory Affairs, Precision Medicine Digital Health at GSK
Applications close November 26. $172K–$286K a year, employer provided.