Regulatory Affairs Associate Jobs in Massachusetts
Regulatory affairs associate jobs in Massachusetts are among the most active in the country, concentrated in the state's dense biopharma, medical device, and life sciences sectors, with openings at every level from entry-level coordinators through senior associates. Boston, Cambridge, and the Route 128 corridor anchor most of the hiring, where established employers like Johnson & Johnson, Hologic, and Takeda maintain significant regulatory operations. FDA submissions, combination products, and post-market surveillance are the most in-demand specialties driving current openings. Find a role that fits below and apply directly.
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Showing 5 of 55+ Regulatory Affairs Associate 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 Associate Jobs in Massachusetts
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Find JobsRegulatory Affairs Associate Jobs by City in Massachusetts
Where Massachusetts roles are concentrated, by current openings.
Regulatory Affairs Associate 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 associate jobs across Massachusetts.
- Bachelor's degree in life sciences, engineering, pharmacy, or a closely related field
- Familiarity with FDA regulations including 21 CFR Parts 820, 803, and 314
- Experience preparing regulatory submissions such as 510(k), PMA, or NDA packages
- Working knowledge of quality management systems and document control processes
- Strong technical writing skills for regulatory correspondence and submission content
- Proficiency with electronic submission tools such as eCTD publishing platforms
Regulatory Affairs Associate Jobs in Massachusetts: Frequently Asked Questions
How do you become a regulatory affairs associate in Massachusetts?
Most regulatory affairs associate roles in Massachusetts require a bachelor's degree in a life sciences, engineering, or pharmacy discipline, though some employers accept other technical fields with relevant coursework. While no Massachusetts state license is required for the role itself, many employers prefer or require candidates to hold or pursue the Regulatory Affairs Certification from the Regulatory Affairs Professionals Society, which is widely recognized across the state's biopharma and medical device industries.
How much do regulatory affairs associates make in Massachusetts?
Regulatory affairs associates 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 associates in Massachusetts?
Employers hiring regulatory affairs associates in Massachusetts right now include Takeda Pharmaceuticals, RadNet, and Sanofi, based on current listings on Migrate Mate as of September 2026. Massachusetts's concentration of global biopharma headquarters and medical device firms along the Route 128 corridor means regulatory teams here often support both domestic FDA filings and international market access work.
Which Massachusetts cities have the most regulatory affairs associate jobs?
The cities with the most regulatory affairs associate openings in Massachusetts are Boston, Cambridge, and Somerville. The concentration reflects the state's life sciences footprint, with Greater Boston and Cambridge home to major biopharma headquarters and research campuses, while suburban Route 128 corridor communities host large medical device and combination product manufacturers that maintain dedicated regulatory affairs departments.
Are there remote regulatory affairs associate jobs in Massachusetts?
Yes, and more than many technical roles, since regulatory affairs work is largely documentation, submission preparation, and cross-functional coordination that translates well to remote settings. About 72% of regulatory affairs associate openings tied to Massachusetts are remote or hybrid as of September 2026, reflecting the desk-based nature of the work. Submission writing, regulatory intelligence, and labeling review tend to be the functions most commonly performed fully remotely.
How can I get hired as a regulatory affairs associate in Massachusetts with little or no experience?
The most realistic entry path is applying to regulatory affairs coordinator or quality assurance associate roles at Massachusetts-based medical device or biopharma companies, which often serve as direct feeders into regulatory associate positions. Large employers across the Route 128 corridor and Greater Boston regularly hire new graduates for these junior roles. Completing a Regulatory Affairs Certification coursework track or gaining internship experience through programs at Massachusetts life sciences companies strengthens a candidate's profile significantly. Adjacent roles in quality, clinical operations, or scientific writing also provide a recognized bridge into regulatory affairs.
Where can I find and apply to regulatory affairs associate jobs in Massachusetts?
You can find and apply to regulatory affairs associate jobs in Massachusetts on Migrate Mate, which lists current Massachusetts openings across the biopharma, medical device, and life sciences sectors. Find roles that fit your background and apply directly to the employers posting them.
See All 55 Regulatory Affairs Associate Jobs in Massachusetts
Find roles in Massachusetts that match your experience and apply in just a few clicks.
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