Regulatory Affairs Manager Jobs in Massachusetts
Regulatory Affairs Manager jobs in Massachusetts are among the most active in the country, concentrated in the life sciences, medical device, and pharmaceutical sectors that anchor the state's economy from entry-level specialist roles through senior director positions. Boston, Cambridge, and the Route 128 corridor are the primary hiring centers, where established employers such as Biogen, Boston Scientific, and Takeda maintain large regulatory affairs teams. The most in-demand specialties are FDA submissions, drug approval pathways, and medical device compliance under 21 CFR Part 820. Find a role that fits below and apply directly.
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Showing 5 of 55+ Regulatory Affairs Manager jobs
Company Overview: Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform with integrated gene editing, delivery and internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.
Position Overview: The Regulatory Director/Sr. Director Regulatory CMC will be responsible for preparing CMC and Quality related health authority agency correspondence and regulatory applications, as well as govern CMC submissions and regulatory compliance support for the development of global products. This position will lead regulatory activities to support high quality CMC sections of regulatory documentation.
Responsibilities:
- Provide regulatory CMC strategic leadership within Regulatory and on cross-functional teams to support development of innovative genomic medicines/ex-vivo and in-vivo therapies.
- Develop and proactively communicate regulatory CMC strategies, risks and key issues in an evolving regulatory landscape.
- Act as the regulatory CMC lead and department representative in matrix teams for development programs.
- Support development of manufacturing, analytical, and supply chain strategies and provide expert regulatory guidance to enable global implementation.
- Define CMC content (data and documentation) requirements for quality sections of regulatory dossiers (IND/CTA/MF and BLA/MAA).
- Plan and manage activities for the preparation of high quality CMC-related global regulatory submission elements, including authoring and/or critical review to ensure compliance with regulatory requirements, scientific excellence, accuracy, source information traceability, and consistency with related filings in accordance with program timelines.
- Providing critical review of detailed scientific information described in CMC documents and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data.
- Evaluation of CMC-related change proposals for regulatory impact and filing requirements; provide strategic regulatory guidance for optimal implementation of changes.
- Develop regulatory processes and procedures to support CMC components of regulatory submissions.
- Support the creation and maintenance of CMC submission templates and dossier standards.
- Lead and support global health authority interactions for CMC-related topics including defining strategy, preparation, and meeting facilitation.
- Support Quality Assurance in preparing and hosting GMP and pre-approval inspections.
- Develops and maintains collaborative partnerships with key internal and external stakeholders.
- Participate in regulatory intelligence activities, monitor regulatory guidelines and trends as they pertain to global CMC regulations and guidance, and provide regulatory advice to CMC and project teams regarding the applicability/impact on internal programs; anticipate and communicate possible regulatory paradigm shifts.
Qualifications
- BA/BS degree in a scientific/engineering discipline with 15+ years experience, 10 of which in the biotech industry; Level will be commensurate with experience.
- 9+ years experience in Regulatory CMC, or related experience (e.g., manufacturing, analytical, quality assurance) with direct technical writing experience for IND/CTA/MF and BLA/MAA submissions.
- Experience with cell and gene therapy and/or lipid nanoparticles is desirable.
- Comprehensive knowledge of regulatory (FDA, EMA, and ICH) guidelines; with a demonstrated ability to articulate and apply these principles to regulatory CMC strategies for novel products.
- Diverse experience including biologics in the cell therapy space, drugs, and international filings preferred.
- Strong experience with CTD format and content regulatory filings.
- Excellent organizational, written/oral communication, and time management skills; ability to communicate complex issues in a succinct and logical manner; strong listening skills.
- Experience with related CMC disciplines (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.
- Ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders; flexibility in responding to changing priorities and/or unexpected events.
- Onsite requirements: candidates are expected to come onsite 1-3 days per week.
Company Overview: Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform with integrated gene editing, delivery and internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.
Position Overview: The Regulatory Director/Sr. Director Regulatory CMC will be responsible for preparing CMC and Quality related health authority agency correspondence and regulatory applications, as well as govern CMC submissions and regulatory compliance support for the development of global products. This position will lead regulatory activities to support high quality CMC sections of regulatory documentation.
Responsibilities:
- Provide regulatory CMC strategic leadership within Regulatory and on cross-functional teams to support development of innovative genomic medicines/ex-vivo and in-vivo therapies.
- Develop and proactively communicate regulatory CMC strategies, risks and key issues in an evolving regulatory landscape.
- Act as the regulatory CMC lead and department representative in matrix teams for development programs.
- Support development of manufacturing, analytical, and supply chain strategies and provide expert regulatory guidance to enable global implementation.
- Define CMC content (data and documentation) requirements for quality sections of regulatory dossiers (IND/CTA/MF and BLA/MAA).
- Plan and manage activities for the preparation of high quality CMC-related global regulatory submission elements, including authoring and/or critical review to ensure compliance with regulatory requirements, scientific excellence, accuracy, source information traceability, and consistency with related filings in accordance with program timelines.
- Providing critical review of detailed scientific information described in CMC documents and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data.
- Evaluation of CMC-related change proposals for regulatory impact and filing requirements; provide strategic regulatory guidance for optimal implementation of changes.
- Develop regulatory processes and procedures to support CMC components of regulatory submissions.
- Support the creation and maintenance of CMC submission templates and dossier standards.
- Lead and support global health authority interactions for CMC-related topics including defining strategy, preparation, and meeting facilitation.
- Support Quality Assurance in preparing and hosting GMP and pre-approval inspections.
- Develops and maintains collaborative partnerships with key internal and external stakeholders.
- Participate in regulatory intelligence activities, monitor regulatory guidelines and trends as they pertain to global CMC regulations and guidance, and provide regulatory advice to CMC and project teams regarding the applicability/impact on internal programs; anticipate and communicate possible regulatory paradigm shifts.
Qualifications
- BA/BS degree in a scientific/engineering discipline with 15+ years experience, 10 of which in the biotech industry; Level will be commensurate with experience.
- 9+ years experience in Regulatory CMC, or related experience (e.g., manufacturing, analytical, quality assurance) with direct technical writing experience for IND/CTA/MF and BLA/MAA submissions.
- Experience with cell and gene therapy and/or lipid nanoparticles is desirable.
- Comprehensive knowledge of regulatory (FDA, EMA, and ICH) guidelines; with a demonstrated ability to articulate and apply these principles to regulatory CMC strategies for novel products.
- Diverse experience including biologics in the cell therapy space, drugs, and international filings preferred.
- Strong experience with CTD format and content regulatory filings.
- Excellent organizational, written/oral communication, and time management skills; ability to communicate complex issues in a succinct and logical manner; strong listening skills.
- Experience with related CMC disciplines (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.
- Ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders; flexibility in responding to changing priorities and/or unexpected events.
- Onsite requirements: candidates are expected to come onsite 1-3 days per week.
See All 55 Regulatory Affairs Manager Jobs in Massachusetts
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Find JobsRegulatory Affairs Manager Jobs by City in Massachusetts
Where Massachusetts roles are concentrated, by current openings.
Regulatory Affairs Manager Job Market in Massachusetts
A snapshot from current Massachusetts openings, updated as new roles post.
Who's Hiring
Top Industries Hiring
- Biotechnology & Pharmaceuticals
- Science & Research
- Healthcare & Medical Services
- Consulting & Professional Services
- Medical Devices
What Massachusetts Employers Look For
The qualifications that appear most often in regulatory affairs manager jobs across Massachusetts.
- Bachelor's degree in life sciences, pharmacy, chemistry, or a related field required
- Direct experience with FDA regulatory submissions including INDs, NDAs, or 510(k)s
- Familiarity with 21 CFR regulations and ICH guidelines for pharmaceutical or device products
- RAC certification from the Regulatory Affairs Professionals Society strongly preferred
- Experience managing cross-functional teams through regulatory review and approval cycles
- Strong technical writing skills for preparing regulatory documents and agency correspondence
Regulatory Affairs Manager Jobs in Massachusetts: Frequently Asked Questions
How do you become a regulatory affairs manager in Massachusetts?
Most regulatory affairs managers in Massachusetts start with a bachelor's degree in a life science, engineering, or pharmacy discipline, then build several years of experience in a regulated industry such as biotech, pharma, or medical devices. Massachusetts does not require a state-issued license specific to regulatory affairs, but the RAC credential from the Regulatory Affairs Professionals Society is widely expected by Massachusetts employers and strengthens candidacy at every level.
How much do regulatory affairs managers make in Massachusetts?
Regulatory affairs managers in Massachusetts earn a median of about $102,060 a year, based on May 2025 Bureau of Labor Statistics wage data, ranging from around $63,340 for the lowest 10% to over $161,920 for the top 10%. Pay rises with experience, specialty, and employer.
Which companies hire regulatory affairs managers in Massachusetts?
Employers hiring regulatory affairs managers in Massachusetts right now include Takeda Pharmaceuticals, RadNet, and Sanofi, based on current listings on Migrate Mate as of September 2026. Massachusetts's dense concentration of biotech and medical device headquarters along Route 128 and in the Kendall Square area means hiring activity in this role remains consistent throughout the year.
Which Massachusetts cities have the most regulatory affairs manager jobs?
Boston, Cambridge, and Somerville have the most regulatory affairs manager openings in Massachusetts. Boston and Cambridge dominate because of the Kendall Square biotech cluster and major pharmaceutical headquarters, while suburban Route 128 corridor cities draw significant hiring from medical device and specialty pharma companies anchored there.
Are there remote regulatory affairs manager jobs in Massachusetts?
Yes, and more than most fields. About 72% of regulatory affairs manager openings tied to Massachusetts are remote or hybrid as of September 2026, reflecting the document-heavy and analytical nature of much of the work. Submission writing, labeling review, and regulatory intelligence roles are the most consistently offered in remote or hybrid arrangements, while positions requiring hands-on lab or manufacturing site oversight tend to be fully on-site.
How can I get hired as a regulatory affairs manager in Massachusetts with little or no experience?
The most realistic entry path is a regulatory affairs associate or coordinator role at a Massachusetts biotech or medical device company, where you support submissions and document management before moving into a management track. Large Massachusetts employers in the Cambridge and Waltham corridors regularly bring on candidates from adjacent roles such as quality assurance, clinical operations, or scientific writing. Earning the RAC credential or completing a graduate certificate in regulatory science gives candidates a clear edge when competing for first roles.
Where can I find and apply to regulatory affairs manager jobs in Massachusetts?
You can find and apply to regulatory affairs manager jobs in Massachusetts on Migrate Mate, which lists current openings across the state. Find roles that fit your background and apply directly to the ones that match.
See All 55 Regulatory Affairs Manager Jobs in Massachusetts
Find roles in Massachusetts that match your experience and apply in just a few clicks.
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