Senior Regulatory Affairs Specialist Hologic IncSenior Regulatory Affairs SpecialistCambridge, MA$40,000–$50,000 / yearTo deliver on that purpose, we need strong regulatory expertise that helps bring new products to market, keeps mature products compliant, and ensures our submissions, labeling, technical files, and product documentation meet global regulatory expectations. This role is ideal for a regulatory professional with strong knowledge of US, EU, and Canadian requirements who enjoys working cross-functionally with Regulatory Affairs, R&D, Clinical, Quality, Marketing, and international regulatory teams.
Executive Director, Global Regulatory Affairs CMC Early Development 3316 Takeda Development Center AmericasExecutive 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).
NewVice President, Regulatory Affairs Aura Biosciences Inc.Vice President, Regulatory AffairsBoston, MA$295,000–$375,000 / yearThe successful candidate will bring deep experience across all phases of oncology drug development and commercialization and a proven track record of leading interactions with global Health Authorities resulting in successful product approvals. The Vice President, Regulatory Affairs will provide strategic leadership for all global regulatory activities across the company's oncology portfolio, with primary focus on ocular oncology indications.
Director, Business Development Regulatory Affairs Job Details | Olympus Corporation Of The Americas OlympusDirector, Business Development Regulatory Affairs Job Details | Olympus Corporation Of The AmericasWestborough, 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.
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.
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.
Co-op - Cybersecurity & Data Analytics (Ultrasound Regulatory Affairs) - Cambridge, MA - January 2027 PhilipsCo-op - Cybersecurity & Data Analytics (Ultrasound Regulatory Affairs) - Cambridge, MA - January 2027Cambridge, MA$29–$32 / hourThe 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. Assist in organizing, analyzing, and maintaining cybersecurity-related data to identify trends, improve visibility, and support informed decision-making across regulatory and cross-functional teams.
Senior Regulatory Affairs Specialist Smith & Nephew PlcSenior Regulatory Affairs SpecialistMansfield, MA$101,500–$152,250 / yearThe anticipated base compensation range for this position is $101,500.00 - $152,250.00 USD annually and the compensation offered will depend on the candidate's qualifications, job-related knowledge/skills, geographical location. As a Senior Regulatory Affairs Specialist, you will play a key role in developing regulatory strategies, securing global product approvals, and ensuring compliance throughout the product lifecycle.
Sr. Manager, Regulatory Affairs AlkermesSr. Manager, Regulatory AffairsWaltham, MARemote$134,000–$149,000 / yearIn 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts' Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy, and a pipeline of clinical and preclinical candidates in development for various psychiatric and neurological disorders.
Regulatory Affairs Specialist II Boston Scientific CorpRegulatory Affairs Specialist IIMarlborough, MAThe anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com-will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. The role will also develop regulatory strategies and provide support for new business development efforts involving external manufacturers, including original equipment manufacturers (OEMs) and contract manufacturers.
Associate Director Advertising and Promotion, Global Regulatory Affairs BiogenAssociate Director Advertising and Promotion, Global Regulatory AffairsCambridge, Massachusetts$152,000–$209,000 / yearThe role of the Associate Director requires the ability to provide regulatory strategic advice primarily for U.S. communications related to disease education, promotional materials and medical/scientific materials for healthcare providers, payors and patients in support of Biogen business objectives. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
Associate Director Advertising And Promotion, Global Regulatory Affairs Biogen IdecAssociate Director Advertising And Promotion, Global Regulatory AffairsCambridge, MA$152,000–$209,000 / yearThe role of the Associate Director requires the ability to provide regulatory strategic advice primarily for U.S. communications related to disease education, promotional materials and medical/scientific materials for healthcare providers, payors and patients in support of Biogen business objectives. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
Manager, Regulatory Affairs Collegium PharmaceuticalManager, Regulatory AffairsStoughton, MA$132,219–$158,400 / yearManage labeling for approved and investigational products, including U.S. prescribing information, clinical trial labeling, and packaging components, while coordinating cross-functional reviews to ensure regulatory compliance, accuracy, and consistency throughout the product lifecycle. They will work in a highly cross-functional manner with internal stakeholders including Medical, Commercial, Legal and Compliance, and Technical Operations to file and maintain the applications for Collegium’s marketed products and development programs in compliance with applicable regulations.
NewVice President, Regulatory Affairs Aura Biosciences IncVice President, Regulatory AffairsBoston, MA$295,000–$375,000 / yearThe successful candidate will bring deep experience across all phases of oncology drug development and commercialization and a proven track record of leading interactions with global Health Authorities resulting in successful product approvals. Position Summary The Vice President, Regulatory Affairs will provide strategic leadership for all global regulatory activities across the companys oncology portfolio, with primary focus on ocular oncology indications.
Associate Director, Global Regulatory Affairs, Precision Medicine & Digital Health Takeda Pharmaceutical Co LtdAssociate Director, Global Regulatory Affairs, Precision Medicine & Digital HealthMARemote$154,400–$242,550 / yearPartner with local/regional regulatory representatives to lead and support lifecycle management regulatory activities for the digital health and precision medicine portfolio, including change impact assessments, regulatory strategy alignment, and execution of required maintenance submissions/notifications to ensure ongoing compliance across markets. Provides strategic and tactical guidance to teams for the delivery of global regulatory strategies to support development and commercialization of biomarkers, diagnostic tests, devices and digital health tools to enhance the value of our products across therapeutic areas and to ensure goals/objectives are met.
Regulatory Affairs Manager - Labeling Cardinal Health IncRegulatory Affairs Manager - LabelingMansfield, MARemote$105,100–$150,100 / yearSymbol and Mark Management: Ensure the correct application of environmental symbols and marks, including those for the WEEE Directive, battery directives (e.g., crossed-out wheeled bin), recycling (e.g., "Green Dot," Mobius loop), and packaging material identification. Risk Management: Ability to apply risk management principles (ISO 14971) to the labeling process, identifying and mitigating risks associated with labeling errors, such as product recalls, shipping holds, or regulatory enforcement actions.
Associate Director Global Regulatory Affairs ApolisAssociate Director Global Regulatory AffairsCambridge, MA$1–$125 / hourThe ideal candidate will have strong experience developing Target Label Profiles (TLPs) and leading labeling strategies for Company Core Data Sheets (CCDS), U.S. Prescribing Information (USPI), and Summary of Product Characteristics (SmPC) updates. Job Description We are seeking an experienced Associate Director, Global Regulatory Affairs – Labeling Lead to lead global labeling strategy and lifecycle management, with a primary focus on biologics .
Regulatory Affairs Professional Siemens HealthineersRegulatory Affairs ProfessionalWalpole, MAFull timeAs a Regulatory Affairs Professional, you will be responsible for : Prepare, submit, and maintain regulatory submissions and lifecycle documentation, including FDA PMA Annual Reports, PMA 30-day notices and supplements, 510(k) submissions and notes to file, IVDR Class D recertifications, significant change notifications, and other regulatory applications as required. "It is Siemens Healthineers' policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.".
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.
Regulatory Affairs Expert - Remote YO AI LabsRegulatory Affairs Expert - RemoteBoston, MassachusettsRemoteThe role involves assessing clinical documents, ensuring compliance with regulatory guidelines, identifying inconsistencies, and providing clear, evidence-based feedback to improve AI-generated regulatory content. We are seeking an experienced Regulatory Affairs Specialist to support AI-driven healthcare projects by reviewing and evaluating regulatory documentation.