Regulatory Affairs Manager Jobs in Pennsylvania
Regulatory Affairs Manager jobs in Pennsylvania are among the most active in the country, concentrated in pharmaceutical manufacturing, medical devices, and life sciences across a state with one of the deepest industry clusters on the East Coast, with openings from associate-level managers through senior directors. Philadelphia, Pittsburgh, and the Greater Delaware Valley suburbs drive the majority of hiring, with established employers like Johnson & Johnson, Merck, and West Pharmaceutical Services maintaining deep regulatory staffing needs in the region. The most in-demand specialties are FDA submissions, combination products, and post-market surveillance for drug and device approvals. Find a role that fits below and apply directly.
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Showing 5 of 15+ Regulatory Affairs Manager jobs
We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programs, pension plan membership, and shares and savings programme. We embrace modern work practices; our Performance with Choice programme offers a remote or hybrid working model, empowering you to find the optimal balance between remote and in-office work.
Discover more about our company-wide benefits and life at GSK on our webpage Life at GSK | GSK
Find out more about GSK and R&D: Our approach to R&D
Regulatory Affairs Manager, CMC mRNA Vx Development Products
As a Regulatory Affairs Manager in Chemistry, Manufacturing, and Controls (CMC) for mRNA-based vaccine development products, you will lead key regulatory activities that guide products from late-stage development through early lifecycle management. In close partnership and collaboration with cross-functional teams including regulatory, manufacturing, quality, and development, you will help shape regulatory CMC strategies that ensure compliance and timely approvals. We are looking for candidates who are proactive, clear communicators, and eager to grow their expertise as Regulatory CMC Managers. In this role, you will have the chance to make a meaningful impact on global health while advancing your career and aligning with GSK’s mission to unite science, technology, and talent to get ahead of disease together.
This is a hybrid role located in the United States in Upper Providence, PA, Rockville, MD, Waltham, MA or Durham, NC. You will be expected to work on-site regularly and collaborate with colleagues across sites and regions in the United States.
If you are passionate about making a difference in global health, developing your career in regulatory science, and thriving in a collaborative environment, we want to hear from you.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Development and execution of CMC (Module 3/2.3) regulatory strategies for vaccine products, ensuring alignment with U.S. regulatory expectations and global requirements (mainly Europe and Japan), including health authority interactions
- Prepare, review, and check CMC documentation for regulatory submissions (IND/CTA, BLA/MAA/JNDA and early life cycle variations) and consultations to meet regulatory compliance and quality standards.
- Collaborate with and provide timely regulatory advice to cross-functional CMC workstreams and matrix teams including manufacturing and quality to support RA CMC strategy development and flawless execution
- Contribute to planning and tracking of CMC source documents and dossier sections to ensure Right-First-Time submission readiness.
- Identify regulatory risks and propose mitigation plans to ensure smooth project progress and successful submissions.
- Support team members, fostering continuous improvement and sharing best practices in CMC regulatory affairs.
Basic Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
- A minimum of a Bachelor’s degree in life sciences, pharmacy, chemistry, biotechnology, or a related scientific discipline.
- Minimum of 2 years of experience in CMC regulatory affairs, with exposure to vaccine or biologics development and regulatory submissions.
- Minimum of 1 year of experience preparing or contributing to CMC sections of regulatory submissions in the US and EU markets for biologicals and/or vaccines.
Preferred Qualifications & Skills:Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:
- Advanced degree (Master’s or PhD) in a scientific or regulatory field.
- Knowledge of U.S. and global regulatory requirements including FDA regulations, Good Manufacturing Practices (GMP), and guideline standards (e.g. ICH) for biologicals/vaccines.
- Experience working collaboratively within cross-functional teams across regulatory, manufacturing, quality, and development functions.
- Good awareness of AI tools and eagerness to apply them responsibly to increase efficiency and/or quality of RA deliverables.
- Experience with the preparation of regulatory interactions and negotiations including FDA meetings (e.g. Type C or pre-BLA), CHMP Scientific advice and /or PMDA consultations.
- Proven ability to develop and implement CMC strategies for complex vaccine or biologics products while managing multiple priorities and deadlines in a dynamic environment.
- Familiarity with electronic submission formats and systems (e.g. Veeva)
- Experience supporting regulatory inspections and providing input on manufacturing or process changes.
Skills
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.
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/
We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programs, pension plan membership, and shares and savings programme. We embrace modern work practices; our Performance with Choice programme offers a remote or hybrid working model, empowering you to find the optimal balance between remote and in-office work.
Discover more about our company-wide benefits and life at GSK on our webpage Life at GSK | GSK
Find out more about GSK and R&D: Our approach to R&D
Regulatory Affairs Manager, CMC mRNA Vx Development Products
As a Regulatory Affairs Manager in Chemistry, Manufacturing, and Controls (CMC) for mRNA-based vaccine development products, you will lead key regulatory activities that guide products from late-stage development through early lifecycle management. In close partnership and collaboration with cross-functional teams including regulatory, manufacturing, quality, and development, you will help shape regulatory CMC strategies that ensure compliance and timely approvals. We are looking for candidates who are proactive, clear communicators, and eager to grow their expertise as Regulatory CMC Managers. In this role, you will have the chance to make a meaningful impact on global health while advancing your career and aligning with GSK’s mission to unite science, technology, and talent to get ahead of disease together.
This is a hybrid role located in the United States in Upper Providence, PA, Rockville, MD, Waltham, MA or Durham, NC. You will be expected to work on-site regularly and collaborate with colleagues across sites and regions in the United States.
If you are passionate about making a difference in global health, developing your career in regulatory science, and thriving in a collaborative environment, we want to hear from you.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Development and execution of CMC (Module 3/2.3) regulatory strategies for vaccine products, ensuring alignment with U.S. regulatory expectations and global requirements (mainly Europe and Japan), including health authority interactions
- Prepare, review, and check CMC documentation for regulatory submissions (IND/CTA, BLA/MAA/JNDA and early life cycle variations) and consultations to meet regulatory compliance and quality standards.
- Collaborate with and provide timely regulatory advice to cross-functional CMC workstreams and matrix teams including manufacturing and quality to support RA CMC strategy development and flawless execution
- Contribute to planning and tracking of CMC source documents and dossier sections to ensure Right-First-Time submission readiness.
- Identify regulatory risks and propose mitigation plans to ensure smooth project progress and successful submissions.
- Support team members, fostering continuous improvement and sharing best practices in CMC regulatory affairs.
Basic Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
- A minimum of a Bachelor’s degree in life sciences, pharmacy, chemistry, biotechnology, or a related scientific discipline.
- Minimum of 2 years of experience in CMC regulatory affairs, with exposure to vaccine or biologics development and regulatory submissions.
- Minimum of 1 year of experience preparing or contributing to CMC sections of regulatory submissions in the US and EU markets for biologicals and/or vaccines.
Preferred Qualifications & Skills:Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:
- Advanced degree (Master’s or PhD) in a scientific or regulatory field.
- Knowledge of U.S. and global regulatory requirements including FDA regulations, Good Manufacturing Practices (GMP), and guideline standards (e.g. ICH) for biologicals/vaccines.
- Experience working collaboratively within cross-functional teams across regulatory, manufacturing, quality, and development functions.
- Good awareness of AI tools and eagerness to apply them responsibly to increase efficiency and/or quality of RA deliverables.
- Experience with the preparation of regulatory interactions and negotiations including FDA meetings (e.g. Type C or pre-BLA), CHMP Scientific advice and /or PMDA consultations.
- Proven ability to develop and implement CMC strategies for complex vaccine or biologics products while managing multiple priorities and deadlines in a dynamic environment.
- Familiarity with electronic submission formats and systems (e.g. Veeva)
- Experience supporting regulatory inspections and providing input on manufacturing or process changes.
Skills
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.
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/
See All 15 Regulatory Affairs Manager Jobs in Pennsylvania
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Where Pennsylvania roles are concentrated, by current openings.
Regulatory Affairs Manager Job Market in Pennsylvania
A snapshot from current Pennsylvania openings, updated as new roles post.
Who's Hiring
Top Industries Hiring
- Chemicals & Materials
- Consulting & Professional Services
What Pennsylvania Employers Look For
The qualifications that appear most often in regulatory affairs manager jobs across Pennsylvania.
- Bachelor's degree in life sciences, pharmacy, chemistry, or a closely related scientific field
- Minimum three to five years of regulatory affairs experience in pharmaceutical or medical device industries
- Demonstrated experience with FDA submissions including INDs, NDAs, PMAs, or 510(k)s
- Working knowledge of FDA regulations, ICH guidelines, and relevant CFR parts
- Experience with electronic submission systems such as eCTD and regulatory tracking software
- RAC certification from the Regulatory Affairs Professionals Society preferred by many Pennsylvania employers
Regulatory Affairs Manager Jobs in Pennsylvania: Frequently Asked Questions
How do you become a regulatory affairs manager in Pennsylvania?
Most regulatory affairs managers in Pennsylvania start with a bachelor's degree in a life sciences discipline and several years in a regulatory, quality, or scientific role within pharma or medical devices. Pennsylvania does not issue a state-specific regulatory affairs license, but employers in the region consistently prioritize the Regulatory Affairs Certification credential issued by the Regulatory Affairs Professionals Society. Building experience in FDA submissions at one of Pennsylvania's many contract research organizations or pharmaceutical manufacturers is the most direct path.
How much do regulatory affairs managers make in Pennsylvania?
Regulatory affairs managers in Pennsylvania earn a median of about $85,580 a year, based on May 2025 Bureau of Labor Statistics wage data, ranging from around $49,910 for the lowest 10% to over $130,990 for the top 10%. Pay rises with experience, specialty, and employer.
Which companies hire regulatory affairs managers in Pennsylvania?
Employers hiring regulatory affairs managers in Pennsylvania right now include Teva Pharmaceuticals, West Pharmaceutical Services, and Cencora, based on current listings on Migrate Mate as of November 2026. Pennsylvania's dense concentration of pharmaceutical headquarters and medical device manufacturers in the Philadelphia suburbs and Pittsburgh corridor makes it one of the most consistent states for regulatory hiring year-round.
Which Pennsylvania cities have the most regulatory affairs manager jobs?
West Chester, Exton, and Pennsylvania post the most regulatory affairs manager openings in Pennsylvania. Philadelphia and its surrounding Delaware Valley suburbs anchor the market because of the high density of pharmaceutical headquarters, biotech firms, and contract manufacturers in that corridor, while Pittsburgh draws openings from its growing life sciences and hospital system sector.
Are there remote regulatory affairs manager jobs in Pennsylvania?
Yes, and more than most fields. About 100% of regulatory affairs manager openings tied to Pennsylvania are remote or hybrid as of November 2026, reflecting the desk-based and document-driven nature of much of the work. Regulatory writing, submission management, and post-market surveillance roles are the most consistently offered in remote or hybrid formats, while positions requiring hands-on lab or manufacturing oversight tend to remain on-site.
How can I get hired as a regulatory affairs manager in Pennsylvania with little or no experience?
The most realistic entry path is moving laterally from a quality assurance, clinical research, or scientific affairs role at a Pennsylvania pharma or device company, where regulatory exposure is built on the job. Large employers in the Greater Philadelphia area and Pittsburgh regularly hire associate regulatory affairs specialists as entry points for candidates with a relevant science degree and some quality or clinical background. Pursuing RAC certification early and targeting contract research organizations in suburban Philadelphia, which frequently take on candidates transitioning from adjacent roles, gives applicants a measurable edge.
Where can I find and apply to regulatory affairs manager jobs in Pennsylvania?
You can find and apply to regulatory affairs manager jobs in Pennsylvania on Migrate Mate, which lists current openings across the state. Find roles that fit your background and apply directly to the employers posting them.
See All 15 Regulatory Affairs Manager Jobs in Pennsylvania
Find roles in Pennsylvania that match your experience and apply in just a few clicks.
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