Associate 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.
Regulatory 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.
Director, Global Trade Waters CorporationDirector, Global TradeMilford, MAThe Director, Global Trade Compliance & Trade Operations is a senior enterprise leader responsible for defining and advancing the company’s global trade strategy, integrating regulatory compliance with world-class import/export operations. This role operates at the intersection of risk governance and supply chain execution, ensuring the organization can scale globally while maintaining strict adherence to international trade laws.
Chief of Staff, Senior Director Global Regulatory Affairs AstraZeneca PlcChief of Staff, Senior Director Global Regulatory AffairsBoston, MA$218,058.40–$327,087 / yearOrganizational Effectiveness and Change: Support organization design, capability building, and talent initiatives; lead change programs and improvements in ways of working that increase clarity, speed, and accountability across the regulatory organization. Cross-Functional and Enterprise Coordination: Partner across R&D, Commercial, Safety, Medical, Legal, Finance, and Procurement to align competing priorities; coordinate across programs, therapy areas, and regions to resolve complex issues that impact filing readiness and approvals.
Chief of Staff, Senior Director Global Regulatory Affairs AlexionChief of Staff, Senior Director Global Regulatory AffairsBoston, MassachusettsOrganizational Effectiveness and Change: Support organization design, capability building, and talent initiatives; lead change programs and improvements in ways of working that increase clarity, speed, and accountability across the regulatory organization. Cross-Functional and Enterprise Coordination: Partner across R&D, Commercial, Safety, Medical, Legal, Finance, and Procurement to align competing priorities; coordinate across programs, therapy areas, and regions to resolve complex issues that impact filing readiness and approvals.
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.
Chief of Staff, Senior Director Global Regulatory Affairs Alexion Pharmaceuticals IncChief of Staff, Senior Director Global Regulatory AffairsBoston, MA$218,058.40–$327,087 / yearOrganizational Effectiveness and Change: Support organization design, capability building, and talent initiatives; lead change programs and improvements in ways of working that increase clarity, speed, and accountability across the regulatory organization. Cross-Functional and Enterprise Coordination: Partner across R&D, Commercial, Safety, Medical, Legal, Finance, and Procurement to align competing priorities; coordinate across programs, therapy areas, and regions to resolve complex issues that impact filing readiness and approvals.
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.
NewSenior Director, Regulatory Affairs Skyhawk Therapeutics IncSenior Director, Regulatory AffairsWaltham, MA$270,000–$350,000 / yearWe use our novel SkySTAR platform (Skyhawk Small molecule Therapeutics for Alternative splicing of RNA) to develop drug candidates directed toward targets for some of the world's most intractable diseases including neurological conditions, cancer, and traditionally "undruggable" targets. The Senior Director, Regulatory Affairs is responsible for planning, developing, and implementing regulatory strategy, submissions, and compliance activities for small molecule programs across early and late-stage development to support global regulatory approvals.
Director, Business Development Regulatory Affairs Olympus CorpDirector, Business Development Regulatory AffairsWestborough, MATake responsibility for all RA aspects of each business development project by a) conducting or overseeing due diligence and integration activities, b) building a functional plan for each project to ensure that functional risks are identified, and actions are planned, and c) securing necessary approvals from RA/regional leadership for due diligence reports and integration strategy/plans. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America.
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.
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 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 – 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.
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.
NewExecutive Director, Regulatory Affairs Strategy - Cell Therapy AstraZeneca PlcExecutive Director, Regulatory Affairs Strategy - Cell TherapyBoston, MA$276,000–$414,000 / 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. GRST Leadership and Talent Development: Lead one or more Global Regulatory Strategy Teams focused on indications, programs, or franchise priorities; provide leadership, coaching, and performance feedback; line-manage 3-7 regulatory team members; contribute to succession planning, capability building, and development of senior regulatory talent.
Director, 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, 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.
NewSenior Director, Regulatory Affairs Skyhawk TherapeuticsSenior Director, Regulatory AffairsWaltham, MassachusettsWe use our novel SkySTAR® platform (Skyhawk Small molecule Therapeutics for Alternative splicing of RNA) to develop drug candidates directed toward targets for some of the world’s most intractable diseases including neurological conditions, cancer, and traditionally “undruggable” targets. The Senior Director, Regulatory Affairs is responsible for planning, developing, and implementing regulatory strategy, submissions, and compliance activities for small molecule programs across early and late-stage development to support global regulatory approvals.
Director, Regulatory Affairs Strategy - Cell Therapy AstraZeneca PlcDirector, Regulatory Affairs Strategy - Cell 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.
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.
Associate Director, Regulatory Affairs CMC Skyhawk Therapeutics IncAssociate Director, Regulatory Affairs CMCWaltham, MA$170,000–$230,000 / yearWorking closely with the Director, RegCMC, you will help serve as a RegCMC point of contact across the organization, partnering with Pharmaceutical Development, Manufacturing, Quality, and Program teams to deliver high-quality, timely regulatory submissions that advance clinical development and support eventual commercialization. We use our novel SkySTAR platform (Skyhawk Small molecule Therapeutics for Alternative splicing of RNA) to develop drug candidates directed toward targets for some of the world's most intractable diseases including neurological conditions, cancer, and traditionally "undruggable" targets.
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.
Executive Director, Global Regulatory Affairs CMC Early Development Takeda Pharmaceutical Co LtdExecutive Director, Global Regulatory Affairs CMC Early DevelopmentBoston, MA$238,000–$374,000 / yearAccountable 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).
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.
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.
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 – 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.
NewSenior Director, Global Regulatory Affairs AlexionSenior Director, Global Regulatory AffairsBoston, MassachusettsAt Alexion (AstraZeneca’s Rare Disease unit), work centres on people living with rare conditions whose journeys demand new thinking every day; this means operating at the edge of science while staying grounded in real patient stories, collaborating across disciplines to turn complex biology into transformative medicines, learning fast in an entrepreneurial environment with the backing of a global biopharma, and growing through tailored development that deepens both leadership capability and empathy for patients and communities we serve. The Senior Director, Global Regulatory Affairs will be responsible for providing senior regulatory leadership across execution teams and US regulatory strategists , with the intention of achieving successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs.
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.
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, Oncology GSK plcAssociate Director Regulatory Affairs, OncologyWaltham, MA$138,750–$231,250 / yearThis role will ensure the development of appropriate global and/or regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy /Integrated Asset plan to ensure the development program meets the needs of the key markets identified and the Medicines Profile. Work with the Early/Medicine Development Team (EDT/MDT) or GRL, to ensure a robust regulatory strategy is in place to support the development program to meet the needs of the key markets identified in the Integrated Asset plan and the Medicine Profile.
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.
Director, Global Regulatory Affairs CMC Takeda Pharmaceutical Co LtdDirector, Global Regulatory Affairs CMCBoston, MA$174,500–$274,230 / yearThis 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) as the GRA CMC Product Lead. • 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.
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.
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).
Director, Regulatory Affairs CMC Madrigal Pharmaceuticals IncDirector, Regulatory Affairs CMCWaltham, MA$207,000–$253,000 / yearThis 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.
Executive Director, Regulatory Affairs Beeline MedicinesExecutive Director, Regulatory AffairsBoston, MassachusettsLed by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully. As a seasoned professional in Regulatory Affairs, develop Global Regulatory strategies and serve as the Global Regulatory Leader (GRL) for assigned Regulatory Project Teams to form global strategies and serve as the US Regulatory Lead (USRL) in the development of US regulatory approaches and execution of US filings.
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.
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.
NewSenior Director, Global Regulatory Affairs Alexion Pharmaceuticals IncSenior Director, Global Regulatory AffairsBoston, MA$272,573–$327,087.60 / yearAt Alexion (AstraZeneca's Rare Disease unit), work centres on people living with rare conditions whose journeys demand new thinking every day; this means operating at the edge of science while staying grounded in real patient stories, collaborating across disciplines to turn complex biology into transformative medicines, learning fast in an entrepreneurial environment with the backing of a global biopharma, and growing through tailored development that deepens both leadership capability and empathy for patients and communities we serve. The Senior Director, Global Regulatory Affairs will be responsible for providing senior regulatory leadership across execution teams and US regulatory strategists, with the intention of achieving successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs.
Sr. Manager Regulatory Affairs CMC Alnylam Pharmaceuticals IncSr. Manager Regulatory Affairs CMCCambridge, MA$144,400–$195,400 / yearHelps to lead the interpretation of regulatory expectations for emerging modalities, including: siRNA and oligonucleotide therapeutics Conjugated delivery systems (e.g., GalNAc and other targeting ligands including biologic modalities) Complex drug substance and drug product configurations Helps to assess CMC implications of new technologies and modalities, including: Impact on product characterization, control strategies, and specifications Regulatory classification considerations (e.g., small-molecule vs biologic paradigms) Manages regulatory compliance activities including periodic regulatory reporting, review of technical documents, and providing regulatory assessments. Broad understanding of: Drug substance and drug product development Analytical characterization and control strategies Regulatory framework across major regions (e.g., US, EU, Japan, China) Strong ability to integrate scientific, technical, and regulatory considerations into clear strategies #LI-KB1 #LI-Hybrid U.S. Pay Range $144,400.00 - $195,400.00 The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting.
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).
Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product Takeda Pharmaceutical Co LtdExecutive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination ProductBoston, MAPlease be aware of identity thieves actively posing as Takeda employees or recruiters posting Takeda-branded jobs online to steal personal information from job seekers. Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product at Takeda Pharmaceutical.
Head of Regulatory Affairs North America Fresenius Medical Care AG & Co KGaAHead of Regulatory Affairs North AmericaWaltham, MAWorking 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, Quality Assurance and Regulatory Affairs Meridian Bioscience IncDirector, Quality Assurance and Regulatory AffairsMAEnsure proper and timely preparation and maintenance of national and international new product submissions, registration/licensing renewals, product listings, post market surveillance reports, import and export documents, safety testing, and other national and international requirements. At least 10 years' experience leading in the medical devices industry; experience regarding medical device design, development and manufacturing regulations, specifically21 CFR Part 820 Quality System Regulation, the IVD Directive 98/79 EC, as well as ISO 13485 requirements.
Associate Director, Global Regulatory Affairs Marketed Products Takeda Pharmaceutical Co LtdAssociate Director, Global Regulatory Affairs Marketed ProductsBoston, MA$153,600–$241,340 / yearAccountable for execution of global regulatory strategy including the provision of global regulatory submissions to local Takeda affiliates in compliance with local regulatory working with regional leads, other functions and vendors. Leads the Global Regulatory Team (GRT) and applicable sub-working groups, such as the Label Working Group, and represents GRT at project team meetings as global and/or regional regulatory lead.