Regulatory Project Manager, CMC Regulatory Affairs
Site Name: USA - Massachusetts - Waltham
Posted Date: Mar 16 2026
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 and coordinate Chemistry, Manufacturing and Controls (CMC) regulatory activities across project teams. You will work with colleagues in regulatory, development, quality, and manufacturing to shape regulatory strategy and deliver high-quality submissions. We value clear communicators who are curious, collaborative, and focused on practical solutions. This role offers growth, visible impact on product development, and alignment with GSK’s mission to unite science, technology and talent to get ahead of disease together.
Key Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Lead CMC regulatory planning and execution for assigned projects, adapting to shifting priorities. Develop CMC regulatory strategies and prepare or coordinate submission documents from clinical phase to lifecycle management. Advise cross-functional teams on regulations, guidance and regional requirements to support timely submissions. Coordinate global dossier assembly, review cycles and responses to regulatory questions. Support supply continuity by ensuring regulatory aspects for manufacturing and release are in place. Share best practices, support continuous improvement, and contribute to CMC subject matter expertise. Manage timelines, deliverables and stakeholders for CMC regulatory activities. Work closely with development, manufacturing and quality teams to align technical and regulatory approaches. Prepare, review and quality-check CMC content for regulatory filings and maintenance submissions. Track regulatory changes and help interpret their impact on project plans and submissions. Coordinate interactions with external partners and regulatory authorities as needed. Support inspections and provide regulatory input for manufacturing or process changes.
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 pharmacy, chemistry, biotechnology or related scientific discipline, or equivalent experience. 2+ years’ experience in CMC regulatory affairs or in pharmaceutical/biopharmaceutical development with direct involvement in regulatory submission preparation.
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
Advanced degree in a relevant scientific or regulatory field. Experience with vaccines or biologics Experience preparing or managing global submissions and interactions with regulatory agencies. Familiarity with regulatory requirements across major regions (for example United States and European Union). Experience supporting post-approval lifecycle activities and manufacturing changes. Proven ability to influence stakeholders and negotiate technical-regulatory issues. Comfort with process improvement and driving efficiencies in regulatory operations. Practical knowledge of CMC requirements for clinical and commercial submissions. Experience working in cross-functional teams and managing competing priorities. Strong written and verbal communication skills with attention to detail. Ability to work independently and collaboratively in a matrix environment.
Work Model
This role is hybrid. You will be expected to be on-site regularly and collaborate across sites and with global colleagues.
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• 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 $113,850 to $189,750.
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 236,250 to PLN 393,750 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.Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. 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 - usrecruitment.adjustments@gsk.com 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. 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/
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