Regulatory Affairs Specialist Jobs in Massachusetts
Regulatory Affairs Specialist jobs in Massachusetts are among the most active in the country, concentrated in the life sciences, biotech, and medical device sectors that anchor the state's economy at every level from entry-level coordinator through senior director. Boston, Cambridge, and the Route 128 corridor are the primary hiring centers, where established employers such as Biogen, Boston Scientific, and Thermo Fisher Scientific maintain large regulatory teams. The most consistent demand is for specialists in FDA submissions, combination products, and quality management systems. Find a role that fits below and apply directly.
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Showing 5 of 55+ Regulatory Affairs Specialist 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 Specialist Jobs in Massachusetts
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Find JobsRegulatory Affairs Specialist Jobs by City in Massachusetts
Where Massachusetts roles are concentrated, by current openings.
Regulatory Affairs Specialist 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 specialist jobs across Massachusetts.
- Bachelor's degree in life sciences, engineering, chemistry, or a closely related field
- Experience with FDA submissions including 510(k), PMA, BLA, or NDA filings
- Familiarity with 21 CFR regulations, ICH guidelines, and GxP quality standards
- Proficiency preparing and reviewing technical documentation and regulatory dossiers
- Experience supporting audits, inspections, or interactions with FDA or other regulatory agencies
- Strong cross-functional collaboration skills working with R&D, quality, and manufacturing teams
Regulatory Affairs Specialist Jobs in Massachusetts: Frequently Asked Questions
How do you become a regulatory affairs specialist in Massachusetts?
Most regulatory affairs specialists in Massachusetts start with a bachelor's degree in a life sciences or engineering discipline, then build experience in quality assurance, clinical operations, or product development before moving into a dedicated regulatory role. Massachusetts does not require a state-issued license for this position. Many employers prefer or require the Regulatory Affairs Certification issued by the Regulatory Affairs Professionals Society, which demonstrates competency across FDA frameworks relevant to the state's dominant biotech and medical device industries.
How much do regulatory affairs specialists make in Massachusetts?
Regulatory affairs specialists 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 specialists in Massachusetts?
Employers hiring regulatory affairs specialists in Massachusetts right now include Takeda Pharmaceuticals, RadNet, and Sanofi, based on current listings on Migrate Mate as of September 2026. Massachusetts's high concentration of FDA-regulated biotech, pharmaceutical, and medical device companies means hiring is sustained year-round rather than tied to a single industry cycle.
Which Massachusetts cities have the most regulatory affairs specialist jobs?
Boston, Cambridge, and Somerville have the most regulatory affairs specialist openings in Massachusetts. Boston and Cambridge lead because of the dense cluster of biotech headquarters, academic medical centers, and established pharmaceutical firms along the Kendall Square corridor and in the Seaport district, while suburban Route 128 communities like Waltham, Lexington, and Marlborough contribute significantly due to the large medical device and life sciences campuses based there.
Are there remote regulatory affairs specialist jobs in Massachusetts?
Yes, and more than many specialized roles, because much of the work involves reviewing documents, preparing submissions, and coordinating with cross-functional teams rather than hands-on laboratory or manufacturing tasks. About 72% of regulatory affairs specialist openings tied to Massachusetts are remote or hybrid as of September 2026. Submission writing, labeling review, and regulatory strategy roles tend to be the most consistently remote, while positions tied to ongoing site inspections or manufacturing oversight are more likely to require on-site presence.
How can I get hired as a regulatory affairs specialist in Massachusetts with little or no experience?
The most realistic entry path is through a quality assurance associate, clinical research coordinator, or regulatory affairs coordinator role at a Massachusetts biotech or medical device company, which builds direct familiarity with FDA-regulated environments. Large employers such as Biogen and Boston Scientific hire into rotational programs and associate-level regulatory roles designed for candidates with limited experience. Pursuing the Regulatory Affairs Certification candidate track while in an adjacent role and building hands-on experience with documentation systems gives candidates a concrete edge in a competitive market.
Where can I find and apply to regulatory affairs specialist jobs in Massachusetts?
You can find and apply to regulatory affairs specialist jobs in Massachusetts on Migrate Mate, which lists current openings from employers across the state. Find roles that fit your experience level and target location, then apply directly to the ones that match.
See All 55 Regulatory Affairs Specialist Jobs in Massachusetts
Find roles in Massachusetts that match your experience and apply in just a few clicks.
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