Regulatory Affairs Analyst Jobs in Massachusetts
Regulatory affairs analyst jobs in Massachusetts sit in one of the most active hiring markets in the country, concentrated in life sciences, pharmaceuticals, and medical devices across Greater Boston, Cambridge, and the Route 128 corridor. Major employers with lasting Massachusetts footprints include Biogen, Boston Scientific, and Takeda, each running dedicated regulatory functions across multiple product lines. Demand is strongest in FDA submissions, clinical trial compliance, and combination product regulation, with openings at everything from entry associate to senior director level. Find a role that fits below and apply directly.
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Showing 5 of 55+ Regulatory Affairs Analyst 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 Analyst Jobs in Massachusetts
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Find JobsRegulatory Affairs Analyst Jobs by City in Massachusetts
Where Massachusetts roles are concentrated, by current openings.
Regulatory Affairs Analyst 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 analyst jobs across Massachusetts.
- Bachelor's degree in life sciences, pharmacy, chemistry, or a related scientific field
- Experience preparing FDA submissions including 510(k), PMA, NDA, or BLA packages
- Familiarity with CFR Title 21 regulations and ICH quality guidelines
- Proficiency with electronic submissions and document management systems such as Veeva
- Strong written communication skills for authoring regulatory documents and correspondence
- RAC certification from the Regulatory Affairs Professionals Society preferred by many Massachusetts employers
Regulatory Affairs Analyst Jobs in Massachusetts: Frequently Asked Questions
How do you become a regulatory affairs analyst in Massachusetts?
Start with a bachelor's degree in a life sciences, pharmacy, engineering, or chemistry field, which is the baseline most Massachusetts employers require. Massachusetts does not issue a state license specific to regulatory affairs, so credentialing centers on industry certification: the Regulatory Affairs Professionals Society offers the RAC credential, which many Boston-area and Route 128 employers list as preferred. Building experience through quality assurance, clinical operations, or laboratory roles at a Massachusetts biotech or medical device company is the most common entry path.
Which companies hire regulatory affairs analysts in Massachusetts?
Massachusetts regulatory affairs analyst roles are posted by Takeda Pharmaceuticals, RadNet, and Sanofi and others right now, based on current listings on Migrate Mate as of September 2026. Massachusetts's dense concentration of pharmaceutical headquarters, contract research organizations, and medical device firms means openings appear across a wide range of company sizes, from global biopharmaceuticals to early-stage Cambridge startups.
Which Massachusetts cities have the most regulatory affairs analyst jobs?
Boston, Cambridge, and Somerville account for the greatest share of regulatory affairs analyst openings in Massachusetts. Greater Boston and Cambridge anchor the market because of the Kendall Square biotech cluster and major pharmaceutical headquarters, while suburban Route 128 cities like Waltham and Lexington draw strong demand from the medical device and diagnostics companies based along that corridor.
Are there remote regulatory affairs analyst jobs in Massachusetts?
Yes, and more than most fields, because the work centers on document review, submission writing, and cross-functional communication that translates well to remote settings. About 72% of regulatory affairs analyst openings tied to Massachusetts are remote or hybrid as of September 2026, reflecting the document-heavy nature of the role. Submission writing, regulatory intelligence, and labeling review are the functions most frequently offered on a fully remote basis.
How can I get hired as a regulatory affairs analyst in Massachusetts with little or no experience?
The most realistic entry path is moving laterally from a quality assurance, clinical data, or laboratory role at a Massachusetts life sciences company, where you already understand regulatory frameworks. Large Massachusetts employers including Biogen and Boston Scientific hire regulatory associates and post-doctoral fellows into structured programs that build submission experience from the ground up. Earning the RAC foundation certificate while in an adjacent role signals commitment and gives candidates a concrete edge when applying to associate-level openings in the Boston and Cambridge market.
Where can I find and apply to regulatory affairs analyst jobs in Massachusetts?
You can find and apply to regulatory affairs analyst jobs in Massachusetts on Migrate Mate, which lists current Massachusetts openings across life sciences, pharmaceuticals, and medical devices. Find the roles that fit your background and apply directly through the listings.
See All 55 Regulatory Affairs Analyst Jobs in Massachusetts
Find roles in Massachusetts that match your experience and apply in just a few clicks.
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