

New · posted Nov 10
GSK · Pharmaceuticals
Manager / Associate Director - Global Regulatory Strategy (Respiratory, Immunology & Inflammation)
- United States +2 more
- Hybrid
- Full-time
- Director
The role
The Manager / Associate Director ensures the development of appropriate global and regional regulatory strategies and their execution for assigned assets to ensure the development program meets the needs of the key markets identified and the Medicines Profile (and is consistent with the Medicines Development Strategy / Integrated Asset plan).
Key to delivery in this role is ensuring compliance with internal GSK process and policies, as well as with appropriate regulatory requirements to deliver the best possible labelling to meet the Medicine Profile (commensurate with the available data).
We are seeking a talented Regulatory Affairs professional with strong knowledge / experience to join our Respiratory, Immunology & Inflammation (RII) Global Regulatory Strategy team. This role reports directly to a Director (Team Lead) for Therapeutic Groups (RII).
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
What you need
Basic Qualifications
- Degree-educated in relevant scientific or technical discipline (or very strong relevant experience).
- Relevant regulatory affairs experience in the EU and/or US and other major markets. Experience should include, for example, developing and implementing regional strategies, managing regulatory interactions, submissions, and review processes.
- Clinical regulatory experience is a must, with knowledge of all phases of the drug development process.
- Ability to develop necessary specialist knowledge for the product or area of medicine.
- Proficiency in digital tools and AI to enhance project delivery and drive efficiency and innovation.
This role is a great opportunity to be instrumental in developing and delivering subject matter expertise across GSK. As this role is multi-faceted and includes liaising with a wide variety of key-stakeholders you must have strong experience of working in complex technical situations, with demonstrable clear problem-solving approach to your work. Strong people skills and a proven ability to influence people to achieve and drive performance are also pre-requisites for this role.
Business Resilience, Communication, Digital Fluency, Matrix Leadership, Pharmaceutical Regulatory Compliance, Policy Advocacy, 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 $138,600 to $231,000. 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.Belgium Salary Range / Fourchette salariale – Belgique: EUR 89,250 to EUR 148,750The annual gross base salary range for new hires in this position is listed above for each applicable location. These ranges take into account a number of factors including the candidate’s skills, experience, education level and the market rate for the role. In addition, this position may offer an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. More detailed information on the total benefits package will be supplied during the recruitment process. This role is available for applicants from multiple locations, and therefore salary ranges for certain locations are also shown. 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 candidate’s skills, experience, education level and the market rate for the role. Offers are typically made within the advertised range based on the candidate’s skills, experience and qualifications, with the upper end generally reserved for highly experienced candidates or other exceptional circumstances aligned with these criteria.
Preferred Qualificationsnice to have
- Experience of all phases of the drug development process in regulatory affairs.
- Knowledge of clinical trial and licensing requirements in all major countries in the region and ideally knowledge of other key Agency processes globally.
- Experience in relevant therapy area (especially Immunology & Inflammation) is a plus.
What you'll do
- Proactively develop regulatory strategies that will deliver the needs of the local region(s), taking into account the needs of other regions globally.
- Implement the regional strategy(s) in support of the project globally.
- Manage regulatory interactions and the review processes in local regions.
- Ensure appropriate interaction with global/regional counterparts and commercial teams in local region.
- Ensure compliance with global/regional requirements at all stages of product life.
- Assess precedent, regulatory intelligence and competitive environment from a regulatory perspective for the region and the impact this will have on the regulatory strategy for an asset
Pay and benefits
$138,600 – $231,000 a year
Employer providedHealth care and other insurance benefits
Retirement benefits
Paid holidays
Vacation
Paid caregiver/parental and medical leave
Annual bonus
Where you'll work
United States +2 moreHybridOpen in Maps (opens in a new tab)
Also posted for: Upper Providence, PA · Durham, NC
Working conditions
Work arrangement
This role is hybrid. Regular on-site collaboration is mandatory. Typical schedule will be two to three days on-site per week.

From the posting
About GSK
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: https://www.gsk.com/en-gb/innovation/
APPLICATION CLOSING DATE – Monday 7th of December 2026 (COB).
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.
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 [email protected] where you can also request a call.
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 10, 2026
Salary intelligence
How the pay compares
This role's midpoint is 26% below the US median for Regulatory Strategy roles at this level.
This roleEmployer provided
Director roles in the US45 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $138,600 | — | $231,000 |
| All US (middle half) | $227,500 | $250,500 | $272,500 |
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 10, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Strategy
The general path across 90 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 20 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Regulatory submissions4
- Collaboration and leadership4
- GMP and compliance3
- Lab testing and methods1
- Documentation and SOPs1
- 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
- 37
- Open roles
- 37
- Distinct roles
- 8
- Locations
By discipline
- Clinical19 51%
- Quality13 35%
- Regulatory5 14%
By level
- Director20 54%
- Associate & Specialist8 22%
- Manager4 11%
More roles at GSK
- View role
Director, Regulatory Affairs, Precision Medicine Digital Health
Waltham, MA · HybridDirectorPharmaceuticals$172K–$286K
- View role
Director, Global Regulatory Strategy, Oncology
Upper Providence, PA · HybridDirectorPharmaceuticals$172K–$286K
- View role
Director, Global Regulatory Strategy
Waltham, MA · HybridDirectorPharmaceuticals$172K–$286K
- View role
Executive Medical Director, Early Clinical Development Lead - Oncology - Lung & Head/Neck Cancers
Upper Providence, PA +1 more · HybridDirectorPharmaceuticals$284K–$474K
Similar Regulatory Strategy roles elsewhere
- View role
Dist. Scientist, Regulatory Liaison
MerckRemote, USDirectorPharmaceuticals$232K–$365K
- View role
Senior Regulatory Affairs Director- Infectious Diseases
AstraZenecaGaithersburg, MD · HybridDirectorPharmaceuticals$218K–$327K
- View role
Senior Director, Regulatory Strategy Leader-Oncology
IQVIADurham, NCDirectorPharmaceuticals$186K–$519K
- View role
Regulatory Affairs Director
AstraZenecaCambridge, MA · HybridDirectorPharmaceuticals$186K–$279K
Manager / Associate Director - Global Regulatory Strategy (Respiratory, Immunology & Inflammation) at GSK
Applications close December 8. $139K–$231K a year, employer provided.


