Regulatory Affairs Jobs in Massachusetts
Regulatory affairs jobs in Massachusetts are among the most active in the country, concentrated in the state's world-leading life sciences, biotechnology, and medical device sectors, with openings at every level from entry-level specialist to senior director. Boston, Cambridge, and the Route 128 corridor are the primary hiring hubs, home to major employers such as Pfizer, Takeda, and Boston Scientific, which maintain substantial regulatory functions in the state. FDA submissions, pharmaceutical quality compliance, and medical device regulatory strategy are the most in-demand specializations. Find a role that fits below and apply directly.
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Showing 5 of 55+ Regulatory Affairs 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 Jobs in Massachusetts
Find roles in Massachusetts that match your experience and apply in just a few clicks.
Find Regulatory Affairs JobsRegulatory Affairs Jobs by City in Massachusetts
Where Massachusetts roles are concentrated, by current openings.
Regulatory Affairs 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 jobs across Massachusetts.
- Bachelor's degree in life sciences, pharmacy, or a related scientific discipline required
- Working knowledge of FDA regulations including 21 CFR and ICH guidelines
- Experience preparing and submitting INDs, NDAs, 510(k)s, or PMAs preferred
- Familiarity with Massachusetts-based biotech or medical device regulatory environments
- Strong technical writing skills for regulatory submissions and internal documentation
- RAC certification from the Regulatory Affairs Professionals Society considered an advantage
Regulatory Affairs Jobs in Massachusetts: Frequently Asked Questions
How do you become a regulatory affairs specialist in Massachusetts?
Most regulatory affairs roles in Massachusetts require at minimum a bachelor's degree in a life sciences field such as biology, chemistry, or pharmacy, though many employers prefer a master's degree. No state-issued license is required to practice regulatory affairs in Massachusetts. Candidates typically build credentials through industry experience, internships at local biotech or medical device companies, and the Regulatory Affairs Professionals Society certification, which Massachusetts employers widely recognize as a professional benchmark.
How much do regulatory affairses make in Massachusetts?
Regulatory affairses 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 dense concentration of pharmaceutical and medical device headquarters along the Route 128 corridor means a large share of openings come from companies with established, multi-team regulatory departments rather than early-stage startups.
Which Massachusetts cities have the most regulatory affairs jobs?
The cities with the most regulatory affairs openings in Massachusetts are Boston, Cambridge, and Somerville. The distribution reflects the life sciences cluster anchored in Boston and Cambridge, where major biotech and pharmaceutical companies maintain regulatory functions, while suburban Route 128 corridor locations such as Waltham and Lexington also generate consistent demand from medical device and specialty pharma employers.
Are there remote regulatory affairs jobs in Massachusetts?
Yes, and more than most fields. Regulatory affairs work is largely document-driven and desk-based, making it well suited to remote and hybrid arrangements. About 72% of regulatory affairs openings tied to Massachusetts are remote or hybrid as of September 2026, reflecting broader industry flexibility in this function. Roles focused on regulatory writing, submissions management, and intelligence tend to carry the highest remote availability, while positions requiring frequent lab or manufacturing site interaction 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 regulatory affairs internship or co-op at one of the many Boston-area or Route 128 biotech and pharmaceutical companies that run formal early-career programs, including larger employers with structured associate or junior specialist roles. Adjacent positions such as quality assurance associate, clinical data coordinator, or regulatory document specialist are common lateral entry points. A life sciences degree combined with RAC exam preparation and any submission or documentation coursework strengthens a candidate's profile considerably with Massachusetts employers.
Where can I find and apply to regulatory affairs jobs in Massachusetts?
You can find and apply to regulatory affairs jobs in Massachusetts on Migrate Mate, which lists current Massachusetts openings across the life sciences, biotech, pharmaceutical, and medical device sectors. Find roles that match your experience and specialization and apply directly from the listings.
See All 55 Regulatory Affairs Jobs in Massachusetts
Find roles in Massachusetts that match your experience and apply in just a few clicks.
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