Regulatory Affairs Director Jobs in Massachusetts
Regulatory Affairs Director jobs in Massachusetts concentrate heavily in life sciences, medical devices, and pharmaceutical manufacturing, making this one of the most active markets in the country for the role at every level from senior manager stepping up to first-time director through VP-level appointments. Most hiring is centered in Boston, Cambridge, and the Route 128 corridor, where established employers like Biogen, Boston Scientific, and Takeda maintain significant operations and regularly seek directors with FDA, CE marking, and combination product expertise. The most in-demand specializations are drug and biologics submissions, medical device 510(k) and PMA pathways, and global regulatory strategy. Find a role that fits below and apply directly.
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Showing 5 of 55+ Regulatory Affairs Director 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 Director Jobs in Massachusetts
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Find JobsRegulatory Affairs Director Jobs by City in Massachusetts
Where Massachusetts roles are concentrated, by current openings.
Regulatory Affairs Director 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 director jobs across Massachusetts.
- Bachelor's degree in life sciences, engineering, or a related field is required
- Minimum of eight to ten years of regulatory affairs experience in pharma or medical devices
- Direct experience managing FDA submissions including INDs, NDAs, BLAs, 510(k)s, or PMAs
- Demonstrated ability to lead cross-functional teams and manage regulatory staff
- Regulatory Affairs Certification from the Regulatory Affairs Professionals Society preferred
- Familiarity with Massachusetts-based contract manufacturers and the regional CRO ecosystem preferred
Regulatory Affairs Director Jobs in Massachusetts: Frequently Asked Questions
How do you become a regulatory affairs director in Massachusetts?
Most regulatory affairs directors in Massachusetts move into the role after accumulating deep submission experience in pharma, biotech, or medical devices, typically starting as a regulatory affairs specialist or manager. Massachusetts does not require a state-issued license for this role. The Regulatory Affairs Professionals Society offers the RAC credential, which is widely respected by Massachusetts employers and can differentiate candidates. A science or engineering degree is the standard foundation, and many employers along the Route 128 corridor and in Cambridge prefer candidates with therapeutic area depth.
How much do regulatory affairs directors make in Massachusetts?
Regulatory affairs directors 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 directors in Massachusetts?
Employers hiring regulatory affairs directors 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 large biotech headquarters and global pharma affiliates means director-level regulatory roles open year-round rather than only during product launch cycles.
Which Massachusetts cities have the most regulatory affairs director jobs?
The cities with the most regulatory affairs director openings in Massachusetts are Boston, Cambridge, and Somerville. Boston and Cambridge dominate because they anchor the largest biotech and pharmaceutical cluster in the country, while suburban Route 128 corridor locations like Waltham and Lexington host numerous regional headquarters and large device manufacturers that consistently require senior regulatory leadership.
Are there remote regulatory affairs director jobs in Massachusetts?
Yes, and more than most fields. About 72% of regulatory affairs director openings tied to Massachusetts are remote or hybrid as of September 2026, reflecting the desk-based and documentation-heavy nature of the role. Strategic regulatory work, submissions management, and agency correspondence tend to be the most remote-compatible responsibilities, while roles tied to manufacturing site compliance or lab-stage development programs are more likely to require on-site presence.
How can I get hired as a regulatory affairs director in Massachusetts with little or no experience?
The most realistic entry path is moving laterally from a regulatory affairs specialist or associate director role within a Massachusetts biotech or medical device company, building a submission portfolio before targeting director titles. Large Massachusetts employers like Biogen and Boston Scientific run structured development programs and often promote from within. Earning the RAC credential signals readiness for director-level responsibility. Regulatory affairs roles at contract research organizations in the Greater Boston area are also strong stepping stones because they provide broad submission exposure across multiple clients and therapeutic areas.
Where can I find and apply to regulatory affairs director jobs in Massachusetts?
You can find and apply to regulatory affairs director jobs in Massachusetts on Migrate Mate, which lists current Massachusetts openings. Find the roles that fit your experience and apply directly to the ones that match.
See All 55 Regulatory Affairs Director Jobs in Massachusetts
Find roles in Massachusetts that match your experience and apply in just a few clicks.
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