NewSenior Regulatory Affairs Specialist Boston Scientific CorpSenior Regulatory Affairs SpecialistMarlborough, MAAt Boston Scientific, our Urology business provides proven, leading solutions to treat several common urology diseases, including kidney stones, benign prostatic hyperplasia (BPH), erectile dysfunction (ED), overactive bladder, urinary and fecal incontinence, and pelvic floor disorders. Act as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy, regulatory pathway development, testing requirements, clarification and follow-up of submissions under review.
Regulatory Affairs Specialist CareerscapeRegulatory Affairs SpecialistBoston, MA$90,000–$125,000 / yearFull timeOur client, a clinical-stage biotechnology company based in Boston's Seaport District, is looking for a Regulatory Affairs Specialist to join their growing regulatory team. The position reports directly to the VP of Regulatory Affairs and works closely with cross-functional teams including R&D, clinical operations, and quality assurance.
Sr. Specialist, Regulatory Affairs LeMaitreSr. Specialist, Regulatory AffairsBurlington, Massachusetts$110,000–$150,000 / yearFull timeProvide support to currently marketed products including: reviewing of engineering change orders, labeling, promotional material, product changes and documentation for changes requiring regulatory approval. Candidate will prepare regulatory submissions for new products/product changes to ensure timely approval for market release and will follow up with regulatory agencies on these submissions.
NewPrincipal Regulatory Affairs Specialist Cardinal Health IncPrincipal Regulatory Affairs SpecialistMansfield, MARemote$80,900–$127,050 / yearThis includes being a regulatory lead for change development projects, new product development, change assessment, US, EU and international regulatory submissions, commercial support, manufacturing support, compliance related activities, systems improvement, and other responsibilities aligned with global medical device regulations and the goals of the Medical Solutions business. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity.
NewSenior Regulatory Affairs Specialist Medtronic PlcSenior Regulatory Affairs SpecialistDanvers, MAThe Interventional Cardiology Therapies (ICT) portfolio provides innovative, minimally invasive cardiovascular technologies designed to help physicians diagnose and treat complex heart and vascular conditions, improve patient outcomes, and support more efficient care delivery across clinical settings. The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
Senior Regulatory Specialists Quanterix CorpSenior Regulatory SpecialistsBillerica, MAPreferred Qualifications: Demonstrated knowledge of FDA regulations and guidance documents including 21CFR 820, ISO 13485, cGXP guidelines, and CLSI gained through at least two (2) years of work experience; Demonstrated ability supporting FDA and CE registrations gained through at least two (2) years of work experience; Demonstrated knowledge of FDA Product approvals, EU Product Approvals, and CLIA/CAP certifications gained through at least two (2) years of work experience; Demonstrated knowledge of FDA and State Inspections gained through at least two (2) years of work experience; and. Our industry-leading precision instruments, digital immunoassay technology and CLIA-certified Accelerator laboratory have supported research that advances disease understanding and management in neurology, oncology, immunology, cardiology, and infectious disease.
Senior Regulatory Affairs Specialist PhilipsSenior Regulatory Affairs SpecialistMA$99,000–$157,000 / yearThe actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. • Lead global regulatory intelligence initiatives, contribute to regulatory and product registration strategies, and help implement global regulatory roadmaps based on the competitive landscape and marketing objectives.
Sr. Specialist, Regulatory Affairs LeMaitre Vascular IncSr. Specialist, Regulatory AffairsBurlington, MA$110,000–$150,000 / yearProvide support to currently marketed products including: reviewing of engineering change orders, labeling, promotional material, product changes and documentation for changes requiring regulatory approval. The Regulatory Affairs Manager will report to the VP of Regulatory Affairs and have the following primary responsibilities: Responsible for preparation of regulatory submissions, including FDA 510(K), CE Technical Documentations, Canadian Device Applications, etc.
Senior International Regulatory Affairs Specialist Butterfly NetworkSenior International Regulatory Affairs SpecialistBurlington, MAIn addition to its medical imaging products, Butterfly Embedded is the Company's Ultrasound-on-Chip licensing and co-development program designed to enable a new wave of ultrasound-enabled technologies across non-competitive healthcare markets and beyond. Utilize and maintain regulatory systems and tools (e.g., document management systems, regulatory submission platforms, and tracking tools) to support ongoing regulatory activities, submissions, and communications with regulatory bodies.
Senior International Regulatory Affairs Specialist Butterfly Network IncSenior International Regulatory Affairs SpecialistBurlington, MAThis role requires a strong ability to translate evolving regulatory requirements-such as EU MDR 2017/745-into clear, actionable plans, while partnering cross-functionally to align regulatory expectations with fast-paced product and software development cycles. In addition to its medical imaging products, Butterfly Embedded is the Company's Ultrasound-on-Chip licensing and co-development program designed to enable a new wave of ultrasound-enabled technologies across non-competitive healthcare markets and beyond.
Regulatory Affairs Specialist I PhilipsRegulatory Affairs Specialist IBedford, MA$71,000–$112,000 / yearYou're the right fit if: You've acquired a minimum of 1+ years' experience in Regulatory Affairs within FDA regulated Medical Device environments with experience/exposure to 510(k)s, PMA supplements, EU MDR Technical Documents, and pre-submissions. The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.
Senior Specialist, Regulatory Affairs Zoll Data Systems, Inc.Senior Specialist, Regulatory AffairsMARemote$101,600–$152,400 / yearSupport a culture of continuous improvement by promoting best practices, fostering innovation, and recognizing and celebrating achievements as well report on key performance indicators (KPIs) to track the progress and impact of continuous improvement efforts. Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
Regulatory Specialist Canadian Nuclear Laboratories LtdRegulatory SpecialistBurlington, MARemoteFrom building the next generation of clean nuclear and hydrogen energy technologies, to developing targeted cancer treatments, to continuing our global leadership in environmental remediation-we are driven by impact, innovation, and purpose. Bachelor''s (Honours) or Master''s or PHD in Engineering or Science from a university of recognized standing; OR membership in an engineering or scientific professional organization authorized by statute to establish qualification for membership in that organization.
Regulatory Affairs Specialist, EHS, North America Henry Schein IncRegulatory Affairs Specialist, EHS, North AmericaMA$56,604–$88,443 / yearDevelop and deliver employee environmental, health, and safety (EHS) awareness and training programs to ensure compliance with applicable federal, state, and international regulations, including OSHA, OSHA State Plans (e.g., Cal/OSHA), DOT, IATA, IMO, and EPA requirements. Proficient in Microsoft Office applications, including PowerPoint, and experienced with project management methodologies and tools commonly used in the medical device or pharmaceutical industries.
Regulatory & Clinical Specialist LivaNova PlcRegulatory & Clinical SpecialistBoston, MARemote$85,000–$95,000 / yearManage the overall development and approval process for assigned documents (CEP, CER, etc.) within timelines, including documentation generation, initiation of the review process, discussions on proposed revisions, and document completion in collaboration with other team members. If you are concerned that an offer of employment might be a scam or that the recruiter is not legitimate, please verify by searching for "See Open Jobs" on https://www.livanova.com/en-us/careers , and check that all recruitment emails come from an @livanova.com email address.
Regulatory & Compliance Specialist - Open Rank University of Massachusetts Medical SchoolRegulatory & Compliance Specialist - Open RankWorcester, MassachusettsResponsibilities: Regulatory & Compliance Specialist I: Gather data, review, and triage the submissions of various initial and continuing review requests ensuring accuracy and the appropriate level of review according to the state and federal regulations. Overview: Under the direction of the Director or designee, the Regulatory and Compliance Specialist is responsible for ensuring research regulatory affairs and compliance with federal and state regulations and institutional policies and procedures.
Senior Regulatory Affairs Program Specialist Zoll Data Systems, Inc.Senior Regulatory Affairs Program SpecialistChelmsford, MARemoteThe Acute Care Technology division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Evaluate and resolve regulatory and technical issues due to extensive knowledge of medical device manufacturing and related regulatory requirements in this product sector through a clear understanding of the product development lifecycle.
Lead Environmental Regulatory Specialist/Project Manager Foth & Van Dyke LLCLead Environmental Regulatory Specialist/Project ManagerMA$110,000–$130,000 / yearSupport Client Managers with developing leads, expanding existing clientele, organizing marketing efforts, contributing to business development activities, assisting in preparation of request for qualifications / request for proposal (RFQ/RFP) response packages and making shortlist presentations. Oversee implementation of specialized projects that include coastal/waterfront development, docks and marinas, beach-dune system enhancement, inlet stabilization and maintenance, waterway improvements including shoreline stabilization structures, stormwater drainage systems, and environmental restoration projects.
Senior Regulatory Affairs Program Specialist ZOLL MedicalSenior Regulatory Affairs Program SpecialistChelmsford, MassachusettsRemoteThe Acute Care Technology division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Essential Functions Evaluate and resolve regulatory and technical issues due to extensive knowledge of medical device manufacturing and related regulatory requirements in this product sector through a clear understanding of the product development lifecycle.
Regulatory & Compliance Specialist Open Rank UMass Chan Medical SchoolRegulatory & Compliance Specialist Open RankWorcester, MARegulatory & Compliance Specialist I: Gather data, review, and triage the submissions of various initial and continuing review requests ensuring accuracy and the appropriate level of review according to the state and federal regulations. Lead Regulatory and Compliance Specialists, ensuring the flow of work and act in the role of content expert on regulations, protocol, and federal and state regulations and institutional policies and procedures.
Senior Specialist, Regulatory Operations Care AccessSenior Specialist, Regulatory OperationsBoston, MARemote$90,000–$100,000 / yearWith programs like Future of Medicine , which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers , which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. The Senior Specialist, Regulatory Operations will oversee, support, and execute all site-level regulatory operational activities for assigned clinical trials in the U.S. They may also support regulatory activities for Canadian sites as needed.
NewSpecialist Regulatory Compliance Environmental American Tower CorpSpecialist Regulatory Compliance EnvironmentalWoburn, MAThis team ensures the appropriate level of environmental review is completed to address the FCC's National Environmental Policy Act's ("NEPA") compliance requirements and the Comprehensive Environmental Response Compensation and Liability Act's ("CERCLA") due diligence considerations for wireless facility development and redevelopment. Contribute to monthly team meetings focused on project review trends, environmental services trends, cross-functional training needs, and customer service best practices.
Principal Specialist - Regulatory Affairs & Compliance Gorton'sPrincipal Specialist - Regulatory Affairs & ComplianceGloucester, MassachusettsMonitor and evaluate emerging regulatory trends, enforcement actions, recalls, and global food safety risks to proactively manage regulatory risks and ensure company strategies remain aligned with current and future compliance requirements. - Provide technical expertise to support Gorton’s businesses in all areas related to ingredients, labeling and claims, legal, governmental and regulatory issues, including FDA registration requirements.
Regulatory Reporting & Compliance Specialist (Hybrid) American Family Insurance GroupRegulatory Reporting & Compliance Specialist (Hybrid)Boston, MA$62,000–$103,000 / yearAdditional Preferred Qualifications: Ability to translate reporting requirements into controlled, repeatable workflows using SQL/BigQuery, Excel, and work-tracking tools (e.g., Jira), with strong documentation to enhance operational efficiency and transparency. Work closely with regulators, states, boards, bureaus, vendors and stat agents related to new and existing regulations, new product, state development, legacy retirements, new data source development.
Regulatory & Compliance Specialist - Open Rank (2026-49995) University of MassachusettsRegulatory & Compliance Specialist - Open Rank (2026-49995)Worcester, MAAll Academic Accounting & Finance Administrative Professional Administrative Support Advancement Biotechnology Clinical Research Environmental Health & Safety Executive Faculty Healthcare Human Resources Information Technology Interns Library Maintenance and Facilities Management Nursing Office Assistant Other Post Doc Professional Technician I Public Safety Research Residents Retail & Dining Services Staff Assistant Staff Associate Volunteer. All Bedford Boston Brockton Brockton Canton Charlestown Danvers Devens Fall River Fitchburg Holyoke Jamaica Plain Jamaica Plan Lincoln Mattapan North Hampton North Quincy Pocasset Shrewsbury Springfield Taunton Tewksbury Waltham Westborough Westfield Woburn Worcester Wrentham.
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.
Sr. Regulatory Affairs Spclst RadNet IncSr. Regulatory Affairs SpclstSomerville, MAQualifications include: • Bachelor's degree in relevant field (or equivalent experience) • 8 - 12 years working in a regulated industry (FDA and Software as a Medical Device preferred) • Strong knowledge of FDA Quality System Regulations, including but not limited to, 21 CFR 11, and 21 CFR 820. Regulatory Affairs Specialist, this position will: • Represent Regulatory Affairs on cross-functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for non-medical devices, and medical devices.
Sr Regulatory Affairs Spec Medtronic PlcSr Regulatory Affairs SpecBoston, MAThis role will partner closely with Geography Regulatory Affairs to support international submissions, government queries, registration documentation, product approval and clearance activities, product demand and release planning, and post-market regulatory compliance to help ensure continued product availability worldwide. The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
Prin Regulatory Affairs Spec Medtronic PlcPrin Regulatory Affairs SpecMAIf you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
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.
Sr. Regulatory Affairs Spclst DeephealthSr. Regulatory Affairs SpclstSomerville, Massachusetts$120,000–$165,000 / yearFull timeRegulatory Affairs Specialist, this position will: · Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for non-medical devices, and medical devices. · Create and ensure maintenance of technical documentation (such as clinical evaluation reports, risk management reports, 510(k) notification) as required for obtaining and/or maintaining regulatory approval/clearance for DeepHealth products.
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.
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.
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.
Vice President, Regulatory Affairs Rhythm Pharmaceuticals IncVice President, Regulatory AffairsBoston, MA$260,000–$360,000 / yearThis leader will oversee a geographically diverse team responsible for execution of international regulatory affairs, regulatory operations, regulatory business operations, labeling, and CMC regulatory, while partnering closely with global regulatory strategy and cross-functional teams. Proven operational leadership with urgency and discipline, including experience leading high-performing teams, team leaders, and subject matter experts through growth, change, and increasing organizational complexity.
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.
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.
Director, Regulatory Strategy – Global Regulatory Lead Beeline MedicinesDirector, Regulatory Strategy – Global Regulatory LeadBoston, MassachusettsDevelop and lead integrated global regulatory strategies for assigned pipeline programs in the I&I portfolio, encompassing pre-IND planning, IND/CTA submission strategy, Phase I/II/III development planning, and regulatory pathway optimization across major global jurisdictions including FDA, EMA, PMDA, and others. The Director, Regulatory Strategy – Global Regulatory Lead is responsible for developing and leading the integrated global regulatory strategies for the company's early-stage and pipeline programs in the immunology and inflammation (I&I) therapeutic area, with a particular focus on lupus and adjacent autoimmune indications.
Sr. Principal Scientist (Sr. Director) - Regulatory Liaison Merck & Co IncSr. Principal Scientist (Sr. Director) - Regulatory LiaisonBoston, MA$190,800–$300,300 / yearRequired Skills: Biological Sciences, Clinical Reporting, Drug Development, Global Health, In Vitro Diagnostics (IVD), Multiple Therapeutic Areas, Pharmaceutical Regulatory Affairs, Process Improvements, Product Approvals, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Issues, Regulatory Strategies, 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.
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.
Postdoctoral Research Fellow-Ironwood Pharmaceuticals, Regulatory Affairs Northeastern UniversityPostdoctoral Research Fellow-Ironwood Pharmaceuticals, Regulatory AffairsBoston, MA$60,315–$85,192.50 / yearThe fellow will have the opportunity to work collaboratively with other functional areas within Ironwood, including global patient safety, clinical development, medical scientific affairs, program management, data sciences, quality and compliance, nonclinical, medical writing and publications, and chemistry, manufacturing, and controls, as well as experience partner interactions and engage in vendor oversight. Responsibilities: The purpose of the Regulatory Affairs (RA) Fellowship is to provide the fellow with training in the functional area and to prepare them to enter an industry role as an individual contributor in Global Regulatory Affairs after the end of their 2-year fellowship.
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.
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.
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.
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.
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.
Manager, Regulatory Affairs Monte Rosa Therapeutics, IncManager, Regulatory AffairsBoston, MassachusettsFull timeResearches and analyzes regulatory information and determines acceptability of data, procedures, and other product-related documentation presented in support of product registration. Under supervision, compiles regulatory submissions, license renewal and annual registrations to the US Food and Drug Administration (FDA) and other regulatory agencies.
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.
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.
Vice President, Regulatory Affairs Rhythm PharmaceuticalsVice President, Regulatory AffairsBoston, MAFull timeThis leader will oversee a geographically diverse team responsible for execution of international regulatory affairs, regulatory operations, regulatory business operations, labeling, and CMC regulatory, while partnering closely with global regulatory strategy and cross-functional teams. Proven operational leadership with urgency and discipline, including experience leading high-performing teams, team leaders, and subject matter experts through growth, change, and increasing organizational complexity.