NewAssociate Director, State Government Affairs - Remote Agios PharmaceuticalsAssociate Director, State Government Affairs - RemoteBoston, MARemote$153,541–$230,312 / yearThe current base salary range for this position is expected to be between $153,541 and $230,312 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. Our team’s proven track record of executional excellence, combined with our depth of expertise and dedication, enables us to develop innovative medicines that reflect the priorities of rare disease communities.
NewSenior Manager, Medical Affairs Operations - Remote Agios PharmaceuticalsSenior Manager, Medical Affairs Operations - RemoteBoston, MARemote$131,035–$196,553 / yearManage the execution of Agios’ patient advocacy conference plans for PK deficiency, thalassemia, and sickle cell disease; participate in cross-functional planning meetings; obtain compliance approval for related materials; and attend virtual and in-person conferences, when needed. Provide operational and project management support to the US patient advocacy team, ensuring smooth day-to-day coordination across priorities, stakeholders, and deliverables, and flex to support various other functions within Medical Affairs as needs arise.
NewRegulatory Affairs Manager Dentsply SironaRegulatory Affairs ManagerBoston, MAThis role works closely with business partners for registrations in their respective countries to ensure compliance globally and acts as an internal champion for initiatives aimed at improving business systems and compliance. • Manages day-to-day activities for less senior Regulatory Affairs professionals, including but not limited to mentoring, coaching, performance reviews, developmental plans, and succession planning.
NewDirector, Regulatory Strategy (Pediatrics) - Remote Agios PharmaceuticalsDirector, Regulatory Strategy (Pediatrics) - RemoteBoston, MARemote$183,549–$275,324 / yearThe current base salary range for this position is expected to be between $183,549 and $275,324 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. This individual will lead cross-functional teams in preparing and overseeing development of compliant, high quality, nonclinical and clinical global regulatory submissions to support development, registration, or life cycle management activities.
NewDirector/Senior Director, Regulatory Labeling Strategy, Advertising, and Promotion, Regulatory Agios PharmaceuticalsDirector/Senior Director, Regulatory Labeling Strategy, Advertising, and Promotion, RegulatoryCambridge, MA$229,562–$344,342 / yearThe current base salary range for this position at the Director level is expected to be between $183,549 and $275,324 annualized and the current base salary range for this position at the Senior Director level is expected to be between $229,562 and $344,342 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. This individual will partner cross-functionally with Legal, Commercial, Corporate Communications, and Medical, as well as other cross-functional stakeholders within the Research and Development organization, to enable compliant, effective messaging, development of labeling, and promotional and non-promotional materials to supports business objectives while protecting the company’s integrity and reputation.
NewSenior Director, Program Leader, Corporate Strategy Agios PharmaceuticalsSenior Director, Program Leader, Corporate StrategyCambridge, MA$229,562–$344,345 / yearDemonstrated ability to drive successful product launch and commercialization of innovative, first-in-class therapies, including lifecycle management (LCM) planning and execution; experience leading programs from late-stage development through commercial readiness and post-launch LCM strategies strongly desired. Define and continuously evolve the Target Product Profile, Clinical Development Plan, regulatory pathway, market access strategy, and commercial positioning in close partnership with cross-functional leaders and aligned with patient needs.
NewSenior Director, Immunology and Translation CSL BehringSenior Director, Immunology and TranslationWaltham, MA$302,000–$350,000You will bring end-to-end experience from early ideation through first-in-disease and will partner closely with cross-functional teams including discovery research, translational medicine, clinical development, and business development to shape and advance CSL Behring's immunology pipeline. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
NewAssociate Director, Scientific Communications & Publications - Remote Agios PharmaceuticalsAssociate Director, Scientific Communications & Publications - RemoteBoston, MARemote$153,000–$230,000 / yearOperating at the intersection of strategy and execution, this role partners closely with cross-functional colleagues and external experts to deliver high‑impact publications and scientific communications that advance both patient care and scientific dialogue. The current base salary range for this position is expected to be between $153,000 and $230,000 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators.
NewSenior Director, Clinical Education and Events Dentsply SironaSenior Director, Clinical Education and EventsBoston, MAThis leader serves as the senior clinical authority for NAM education, ensuring programs meet the needs of practicing clinicians while supporting business priorities, product adoption, and long term customer trust. • Oversee planning and execution of clinical educational events (e.g., courses, workshops, symposia, webinars), ensuring end-to-end operational excellence (logistics, faculty coordination, attendee experience) and alignment to learning objectives.
NewAssociate Director/ Director, Patient Marketing - Remote Agios PharmaceuticalsAssociate Director/ Director, Patient Marketing - RemoteBoston, MARemote$183,549–$275,324 / yearThe current base salary range for this position at the Associate Director level is expected to be between $153,541 and $230,312 annualized and the current base salary range for this position at the Director level is expected to be between $183,549 and $275,324 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. The Associate Director/Director, Patient Marketing will focus on developing and executing the patient strategy in preparation for the future launch of mitapivat, currently in development for sickle cell disease, a vastly underserved community.
NewMedical Director, Sickle Cell Disease, Clinical Development Agios PharmaceuticalsMedical Director, Sickle Cell Disease, Clinical DevelopmentBoston, MA$221,600–$369,333 / yearThe current base salary range for this position is expected to be between $221,600 and $369,333 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. Follow important developments and relevant trends in scientific literature and develop/maintain contracts with external experts to support understanding of the candidate drug effects and to gain strategic insights to the further development and placement of study and overall program.
NewAssociate Director, Clinical Assay Strategy, Flu CSL SeqirusAssociate Director, Clinical Assay Strategy, FluWaltham, MA$179,000–$212,000This role is intended for a recognized subject matter expert who understands the scientific, operational, and regulatory evolution of influenza immunogenicity assessment, including HAI, microneutralization (MN), ELLA, and multiplex platforms, and can strategically navigate assay modernization while maintaining regulatory alignment. Headquartered in Melbourne, Australia, with major manufacturing hubs in Holly Springs, NC, and Liverpool, UK, the company operates the world’s largest cell-based vaccine facility and serves as a primary partner to governments for global pandemic preparedness.
Director of Quality Assurance and Regulatory Affairs Biomedical SearchDirector of Quality Assurance and Regulatory AffairsLittleton, MAThe Director will oversee Quality and Regulatory functions across multiple sites, ensuring compliance with FDA, ISO 13485, and other applicable regulations while partnering closely with Operations, Engineering, and Executive Leadership. This individual will play a key role in shaping quality strategy, strengthening the Quality Management System (QMS), leading audits and CAPA activities, and developing a high-performing QA/RA team.
Senior Director, Regulatory Affairs Bicara TherapeuticsSenior Director, Regulatory AffairsBoston, MassachusettsFICERA specifically addresses a key challenge in solid tumor treatment by enabling immune cell penetration into tumors, reducing fibrosis and immunosuppression while reversing TGF--driven resistance mechanisms - ultimately designed to drive the deep, durable responses that may translate into better outcomes and survival for patients. Founded in 2020, we've built a global team of over 100 employees headquartered in Boston, with a clear focus on advancing our lead asset, ficerafusp alfa, or FICERA - a potentially first-in-class bifunctional EGFR-directed antibody combined with a TGF- ligand trap.
Associate Director Regulatory Affairs Alnylam Pharmaceuticals IncAssociate Director Regulatory AffairsCambridge, MA$170,900–$231,300 / yearAdditional responsibilities include involvement in the writing and oversight of regulatory submissions, coordinating all aspects of paper and electronic regulatory submissions, proactively keeping updated on US regulatory requirements, and interpreting regulatory intelligence for the internal teams. Serve as member of/or lead the Global Regulatory Team, may serve as Regulatory representative in multidisciplinary product subteams or core team for assigned programs and participate as an active team member.
Director, Regulatory Affairs – Global Regulatory Strategy Monte Rosa Therapeutics, IncDirector, Regulatory Affairs – Global Regulatory StrategyBoston, MassachusettsFull timeOverview: Monte Rosa Therapeutics is seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our development programs, with a focus on immunology. Lead the preparation, submission, and maintenance of regulatory applications, including INDs, CTAs, marketing applications, Annual Reports, Orphan Drug Designation, Requests for Fast Track, and other regulatory documents.
NewAssociate Director, Regulatory Affairs CMC Voyager TherapeuticsAssociate Director, Regulatory Affairs CMCCambridge, MassachusettsThe Associate Director of Regulatory Affairs CMC will be responsible for developing, implementing and advising on global Regulatory CMC strategies for new and late stage programs to secure approval of the manufacturing process and control testing for initial clinical trials under INDs/CTAs and transition to appropriate GMP validation to move expeditiously in Phase 3 trials with material suitable for commercialization to support market access for Voyager’s gene therapy products. The qualified candidate will define Regulatory CMC submission strategies and plan, construct, direct, write summaries/reports for CMC sections of INDs, CTAs, BLAs and MAAs including post-approval supplemental applications and coordinate responses during the review/approval by Regulatory authorities.
Associate Director Regulatory Affairs Viridian Therapeutics IncAssociate Director Regulatory AffairsWaltham, MAReporting to the Senior Director, Regulatory Affairs, the Associate Director, Regulatory Affairs will represent Regulatory Affairs on assigned cross-functional teams and lead day-to-day regulatory activities for product development and approval in alignment with the corporate strategy for Viridian's Thyroid Eye Disease (TED) and TSHR portfolio. Communicate with internal and external stakeholders, including members of the leadership teams, to ensure cross-functional alignment, work with Regulatory CMC and Regulatory Operations teams to establish and meet timelines for regulatory submissions.
Executive Director, Regulatory Affairs Strategy - Cell and Gene Therapy AstraZeneca PlcExecutive Director, Regulatory Affairs Strategy - Cell and Gene TherapyBoston, MA$276,127–$414,190 / yearMilestone Delivery and Dossier Excellence: Be accountable for delivery of all project-related regulatory milestones, including probability of regulatory success assessments, mitigation planning, approval strategy, lifecycle planning; lead preparation of regulatory strategy documents and target product labeling; ensure strong strategic planning and construction of the global dossier and core prescribing information; oversee maintenance and compliance for marketed brands where applicable. Accountabilities: Global Regulatory Strategy Leadership: Own the end-to-end global regulatory strategy for a cell and gene therapy product or franchise of exceptional complexity and strategic importance, from current stage through BLA submission, approval, and lifecycle management; may serve in a dual role as Franchise GRL and regional Regulatory Affairs Director.
NewDirector, Regulatory Affairs Liaison, Vaccines & Infectious Diseases Merck & Co IncDirector, Regulatory Affairs Liaison, Vaccines & Infectious DiseasesBoston, MA$210,400–$331,100 / yearRequired Skills: Biological Sciences, Biostatistics, Clinical Judgment, Clinical Trial Planning, Clinical Trials, Communication, Cross-Functional Collaboration, Detail-Oriented, Infectious Disease, Leadership, Medical Writing, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Intelligence, Regulatory Issues, Regulatory Strategy Development, Regulatory Writing. Primary activities include, but are not limited to: Functions with a high degree of independence and provides regulatory oversight for assigned products, functioning as the single, accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.
Senior Director, Regulatory Affairs Strategy - Cell and Gene Therapy AstraZeneca PlcSenior Director, Regulatory Affairs Strategy - Cell and Gene TherapyBoston, MA$218,058–$327,087 / yearAccountabilities: Global Regulatory Leadership: Own the end-to-end global regulatory strategy for a high-complexity cell and gene therapy program, from current stage through BLA submission, ensuring an efficient route to approval with competitive labeling aligned to product attributes and patient, market and business needs. Cross-Functional Product Leadership: Represent Regulatory Affairs on Global Product Teams, shaping development and commercialization plans, contributing to governance presentations and aligning regulatory objectives with clinical, CMC, safety and commercial strategies.
Director, Global Regulatory Affairs Process Excellence and Transformation Vertex Pharmaceuticals IncDirector, Global Regulatory Affairs Process Excellence and TransformationBoston, MA$196,800–$295,200 / yearAs a key member of the GRA Process Optimization Network (GPON), this role consults with cross-team representatives to diagnose operational challenges and deliver scalable, sustainable solutions. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.
Director, Regulatory Affairs – Clinical Strategy Azurity Pharmaceuticals - USDirector, Regulatory Affairs – Clinical StrategyWoburn, MADevelopment and implementation of clinical regulatory strategies and tactics,including but not limited to, Modeling Informed Drug Development (MIDD), real- world data (RWD)/real-world evidence (RWE), and meta-analysis, for pipeline and commercial assets,while considering FDA and other health authority clinical and regulatory requirements. As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Director – Clinical Strategy will conduct in depth analysis of regulatory and clinical information to develop complex strategies supporting potential drug products for development and commercial drug products for expansion of the Azurity portfolio of medications.
Director, Regulatory Affairs - Clinical Strategy Azurity Pharmaceuticals IncDirector, Regulatory Affairs - Clinical StrategyWoburn, MABrief Team/Department Description: As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Director - Clinical Strategy will conduct in-depth analysis of regulatory and clinical information to develop complex strategies supporting potential drug products for development and commercial drug products for expansion of the Azurity portfolio of medications. Principle Responsibilities: • Development and implementation of clinical regulatory strategies and tactics, including but not limited to, Modeling Informed Drug Development (MIDD), real-world data (RWD)/real-world evidence (RWE), and meta-analysis, for pipeline and commercial assets, while considering FDA and other health authority clinical and regulatory requirements.
Director, Regulatory Affairs Strategy - Cell and Gene Therapy AstraZeneca PlcDirector, Regulatory Affairs Strategy - Cell and Gene TherapyBoston, MA$186,232–$279,349 / yearPartnering with senior leaders and global teams, you will lead strategy across key milestones-from expedited designations and Health Authority interactions through major submissions and post-approval maintenance-helping the business deliver transformative therapies at pace and with rigor. In this Director role, you will shape the regulatory path for programs that span oncology, immune-mediated and rare diseases-translating breakthrough science into timely approvals and competitive labeling that make a tangible difference to patients and markets.
Director, Regulatory & Clinical Affairs Nova Biomedical CorpDirector, Regulatory & Clinical AffairsWaltham, MA$210,000–$270,000 / yearThe Director of Regulatory & Clinical Affairs will oversee and lead the Regulatory Affairs Department to ensure global regulatory requirements are met for Nova products, including compliance with US FDA CFR Title 21 Part 820 (Quality System Regulation), ISO 13485:2016, Australian Therapeutic Goods (Medical Devices) Regulations (TG(MD)R Sch. This role serves as Deputy Person Responsible for Regulatory Compliance (PRRC) and is responsible for the leadership, development, and management of an effective and compliant Regulatory Affairs team, working closely with cross-functional partners to ensure processes meet regulatory expectations and support operational excellence.
Associate Director, Regulatory Affairs Rhythm Pharmaceuticals IncAssociate Director, Regulatory AffairsBoston, MA$160,000–$240,000 / yearFor the right candidate, this role offers significant growth potential as you help shape the regulatory future of our rare disease programs and make a meaningful impact on patients lives. At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause.
Senior Director Regulatory Affairs Liaison- General Medicine Merck & Co IncSenior Director Regulatory Affairs Liaison- General MedicineBoston, MA$190,800–$300,300 / yearRequired Skills: Corporate Commercial, Cross-Cultural Awareness, Drug Development, Exercises Judgment, Global Health, Global Market, Healthcare Innovation, Interpersonal Relationships, In Vitro Diagnostics (IVD), Multiple Therapeutic Areas, Oral Communications, Orphan Drugs, Pharmaceutical Regulatory Affairs, Process Improvements, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Issues, Regulatory Management, Regulatory Strategy Development, Written Communication. As the Global Regulatory Lead (GRL), the Senior Principal Scientist functions as the regulatory single, accountable, global point of contact on the project team and interacts with the global regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more company investigational and marketed drugs/biologics in early- and/or late-stage development.
Director, Regulatory Affairs Thermo Fisher Scientific IncDirector, Regulatory AffairsMA$175,000–$219,000 / yearWe provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy.
Sr. Manager/Associate Director, Regulatory Affairs Oruka TherapeuticsSr. Manager/Associate Director, Regulatory AffairsWaltham, CaliforniaOruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. This individual will work closely with cross-functional teams to provide regulatory guidance throughout product development, support health authority interactions, and help ensure the timely preparation and submission of high-quality regulatory applications.
Executive Director, Global Regulatory Affairs CMC Early Development TakedaExecutive Director, Global Regulatory Affairs CMC Early DevelopmentBoston, MassachusettsAccountable for ensuring global CMC content quality and compliance for early development submissions and lifecycle changes through Phase 2 (e.g., IND/CTA modules, IMPD quality sections, amendments, investigator’s brochure CMC, and responses to health authority questions), partnering with regional leads and technical functions to ensure consistent, inspection-ready documentation. Represents Global Regulatory Affairs CMC in senior-level governance and in interactions with global health authorities, including FDA, EMA, MHRA, PMDA, and other agencies as applicable, to enable efficient pathways for early development CMC strategies and submissions (e.g., pre-IND/IND/CTA, amendments, Type B/C meetings, scientific advice).
Sr. Manager/Associate Director, Regulatory Affairs Oruka Therapeutics IncSr. Manager/Associate Director, Regulatory AffairsWaltham, MA$161,000–$187,000 / yearOruka's mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. This individual will work closely with cross-functional teams to provide regulatory guidance throughout product development, support health authority interactions, and help ensure the timely preparation and submission of high-quality regulatory applications.
Executive Director, Regulatory Affairs Dyne Therapeutics IncExecutive Director, Regulatory AffairsWaltham, MA$250,000–$310,000 / yearRole Summary: The Executive Director, Regulatory Affairs serves as a visionary leader who shapes long-term program regulatory strategy, collaborates on regulatory functional strategy, and drives organizational impact across Dyne''s regulatory operations. This position requires a leader who contributes to department-wide strategy, develops corporate policies and processes that influence the organization''s direction, and ensures alignment with the mission of delivering meaningful outcomes for patients.
Associate Director, Regulatory Affairs Rhythm PharmaceuticalsAssociate Director, Regulatory AffairsBoston, MassachusettsFor the right candidate, this role offers significant growth potential as you help shape the regulatory future of our rare disease programs and make a meaningful impact on patients' lives. At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause.
Associate Director Regulatory Affairs – Vascular (on-site) AbbottAssociate Director Regulatory Affairs – Vascular (on-site)Westford, MassachusettsMaintains expert working knowledge of laws, regulations and enforcement decisions related to Quality Assurance (QA), manufacturing and Research & Development (R&D) issues that may impact company operations and decision making; communicates such knowledge to all internal stakeholders. As a manager, the function of an Associate Director, Regulatory Affairs is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation.
Director, Regulatory Affairs, Commercial (Advertising & Promotion) Xenon PharmaceuticalsDirector, Regulatory Affairs, Commercial (Advertising & Promotion)Needham, MassachusettsOur Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions. Our Phase 3 epilepsy program also includes a second FOS study, X-TOLE3, which would support regulatory submissions outside the U.S., and the X-ACKT study in primary generalized tonic-clonic seizures, which would support regulatory submissions for an additional epilepsy indication.
Regulatory Affairs Strategy Director AstraZeneca PlcRegulatory Affairs Strategy DirectorBoston, MA$186,232.80–$279,349.20 / yearCompetitive salary and benefits package on offer: Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. The more experienced you are, the more accountability you will have for strategic leadership including responsibility for development and implementation of the global regulatory strategy for a product/group of products of increasing complexity.
Director, Regulatory Affairs Nova BiomedicalDirector, Regulatory AffairsWaltham, MA$210,000–$270,000 / yearOversees and leads the Regulatory Affairs function to ensure global regulatory requirements are met for Nova products including but not limited to: U.S. FDA 21 CFR Part 820 (Quality Management System Regulation (QMSR), ISO 13485:2016, EU Regulation (EU) 2017/746 (IVDR); UK Medical Devices Regulations 2002 (UK MDR 2002); Australian Therapeutic Goods (Medical Devices) Regulations 2002 (incl. Own post-market regulatory obligations, including vigilance/adverse event reporting, Field Safety Corrective Actions/recalls (as applicable), regulatory reporting, and support for post-market performance follow-up and performance evaluation report updates under IVDR, as well as post-market surveillance and vigilance requirements under UK MDR 2002.
Director, Global Regulatory Affairs CMC TakedaDirector, Global Regulatory Affairs CMCBoston, MassachusettsThis role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows: Independently develops the regulatory CMC strategy and leads the execution of regulatory CMC investigational, registration and post-approval strategies for their assigned product(s) and may serve as the GRA CMC Product Lead, as required. Proactively communicates CMC regulatory strategies, key issues and risks through assigned programs / products development activities and LCM in adequate and timely manner to cross-functional programs/ products teams and management level within GRA CMC, GRA, PS, GMS and QA - as appropriate.
Associate Director, Global Regulatory Affairs CMC Takeda Pharmaceutical Co LtdAssociate Director, Global Regulatory Affairs CMCBoston, MA$153,600–$241,340 / yearProactively communicates CMC regulatory strategies, key issues and risks through assigned programs / products development activities and LCM in adequate and timely manner to cross-functional programs/ products teams and management level within GRA CMC, GRA, PS, GMS and QA - as appropriate. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the teams delivery of critical functions as follows: With minimal supervision, develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products.
Associate Director Regulatory Affairs CMC Alnylam Pharmaceuticals IncAssociate Director Regulatory Affairs CMCMA$170,900–$231,300 / yearLead or help to lead the interpretation of regulatory expectations for emerging modalities, including oligonucleotide therapeutics, conjugated delivery systems (e.g., GalNAc and other targeting ligands), antibody-drug conjugates, peptide conjugates, and biologic or hybrid modalities. This role serves as a key bridge between Research, Pharmaceutical Development, Technical Operations, and Regulatory Sciences, helping to translate evolving science into effective global regulatory CMC strategies.
Director, Global Regulatory Affairs Stoke Therapeutics IncDirector, Global Regulatory AffairsBedford, MA$248,000–$280,000 / yearPosition Purpose: The Director, Global Regulatory Strategy will be responsible for developing and delivering global regulatory strategies to ensure products are developed, approved, and maintained in compliance with health authority requirements and in alignment with the corporate strategy for Stoke's portfolio. Develops and maintains current regulatory knowledge and provides guidance to regulatory staff and company management; identifies the need for new or expanded regulatory policies, processes and SOPs, and approves and ensures implementation to establish a compliant culture.
Associate Director, Regulatory Affairs CMC CRISPR Therapeutics AGAssociate Director, Regulatory Affairs CMCSouth Boston, MA$165,000–$180,000 / yearThe Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY (exagamglogene autotemcel [exa-cel]), the world's first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia. You will work in close collaboration with CMC and global development teams, and with relevant external parties including contract manufacturing organizations, expert consultants, development partners, and global health authorities.
Associate Director, Regulatory Affairs, Advertising, Promotion & Labeling (RA-APL) Intellia Therapeutics IncAssociate Director, Regulatory Affairs, Advertising, Promotion & Labeling (RA-APL)Cambridge, MARemote$193,176–$236,104 / yearThis role works closely with commercial/launch teams, medical affairs, research and development, corporate communications, and legal to ensure external communications, including but not limited to promotional communications, are compliant with regulatory requirements and align with strategic objectives and commercial regulatory strategy. Represents Regulatory on the Commercial Medical, Legal, Regulatory Committee (CMLR) to navigate claims and presentations, providing advice based on the Federal Food, Drug, & Cosmetic Act (FDCA) and implementing regulations impacting advertising & promotional labeling.
Head of Medical Information Director/Senior Director - Medical Affairs Vor BioPharma IncHead of Medical Information Director/Senior Director - Medical AffairsBoston, MA$220,000–$240,000 / yearAs the most senior person in the function the MI lead will be accountable for leading the strategy and operations of the MI function, ensuring accurate, timely, and compliant responses to inquiries from healthcare professionals (HCPs), patients, and internal stakeholders, and be the primary point of accountability with other functions across the company (including, among others, compliance, quality, and safety & pharmacovigilance). Senior Director level: 12+ years of relevant experience in MI or related MA roles within the pharmaceutical or biotechnology industry, with at least 3 years of management or team leadership experience managing direct reports and/or matrixed teams.
Associate Director, Regulatory Affairs Entrada Therapeutics IncAssociate Director, Regulatory AffairsBoston, MARemote$171,000–$204,000 / yearWe are a tight-knit team of experts and leaders in both therapeutic development and rare diseases and are excited to grow and attract colleagues who are ready to join a high-energy, dedicated team that likes to get things done and dramatically improve the lives of patients and their families. We expect multiple clinical data readouts as we advance several DMD programs across the U.K., EU, and U.S. By year-end 2026, we anticipate four clinical-stage programs in our DMD franchise (ENTR-601-44, ENTR-601-45, ENTR-601-50, and ENTR-601-51).
Head of Regulatory Affairs North America Fresenius Medical CareHead of Regulatory Affairs North AmericaWaltham, MassachusettsWorking knowledge of the U.S. Food Drug and Cosmetic Act, and all associated regulations, especially the FDA medical device product approval processes, FDA legislature/regulation, post market approval requirements, and Quality Systems Regulations. Ensures all employees within the assigned team(s) understand and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations; establishing and maintaining effective internal systems and controls to promote compliance.
Director, Regulatory Affairs CMC Madrigal PharmaceuticalsDirector, Regulatory Affairs CMCWaltham, MassachusettsThis role provides strategic, tactical and operational regulatory CMC leadership to support clinical trial applications, market registrations and post-approval submissions, along with managing the day-to-day regulatory CMC activities of assigned projects for development and/or commercial products. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process.
Associate Director, Regulatory Affairs CMC CRISPR TherapeuticsAssociate Director, Regulatory Affairs CMCSouth Boston, MassachusettsThe Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY® (exagamglogene autotemcel [exa-cel]), the world’s first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia. You will work in close collaboration with CMC and global development teams, and with relevant external parties including contract manufacturing organizations, expert consultants, development partners, and global health authorities.
Associate Director, Regulatory Affairs Entrada TherapeuticsAssociate Director, Regulatory AffairsBoston, MassachusettsRemoteWe are a tight-knit team of experts and leaders in both therapeutic development and rare diseases and are excited to grow and attract colleagues who are ready to join a high-energy, dedicated team that likes to get things done and dramatically improve the lives of patients and their families. We expect multiple clinical data readouts as we advance several DMD programs across the U.K., EU, and U.S. By year-end 2026, we anticipate four clinical-stage programs in our DMD franchise (ENTR-601-44, ENTR-601-45, ENTR-601-50, and ENTR-601-51).