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.
Usability and Regulatory Affairs Specialist SentecUsability and Regulatory Affairs SpecialistLincoln, RI$80,000–$100,000 / yearDevelop and maintain usability engineering documentation, including use specifications, task analyses, use-related risk analyses, and the usability engineering file, in accordance with IEC 62366 and FDA guidance. You will work closely with engineering, clinical, and quality teams to identify and mitigate use-related risks—ultimately helping bring high-impact medical technologies to market.
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 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.
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 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.
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.
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.
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.
Manager, Regulatory Affairs Monte Rosa Therapeutics IncManager, Regulatory AffairsBoston, MAResearches 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 – Vascular (on-site) AbbottAssociate Director Regulatory Affairs – Vascular (on-site)Westford, Massachusetts$129,300–$258,700 / yearMaintains 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.
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.".
Usability And Regulatory Affairs Specialist SentecUsability And Regulatory Affairs SpecialistLincoln, RI$90,000–$110,000 / yearDevelop and maintain usability engineering documentation, including use specifications, task analyses, use-related risk analyses, and the usability engineering file, in accordance with IEC 62366 and FDA guidance. You will work closely with engineering, clinical, and quality teams to identify and mitigate use-related risks—ultimately helping bring high-impact medical technologies to market.
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.
Director US Advertising And Promotion Global Regulatory Affairs SanofiDirector US Advertising And Promotion Global Regulatory AffairsCambridge, MA$178,500–$257,833.33 / yearThe Director is responsible for decision-making, direction, and oversight of the day-to-day activities of their assigned products, departmental activities, and direct reports (if applicable) in order to meet internal and external customer needs. About the job: As the Director, US Advertising and Promotion, Global Regulatory Affairs within our GRA Advertising and Promo Team, you will be responsible for decisions, providing strategic direction and oversight for the day-to-day activities for assigned products.
Senior Manager, Regulatory Affairs Avalyn PharmaSenior Manager, Regulatory AffairsBoston, Massachusetts$157,000–$173,000 / yearA minimum of 5-8 plus years of regulatory affairs experience within the pharmaceutical, biotechnology, or combination product industry, with operational support of global clinical trials, and direct authorship of regulatory submissions for investigational and commercial products. AP01 has demonstrated encouraging safety and clinical activity across Phase 1b and an ongoing, multi-year open-label extension trial, with long-term data supporting the potential to preserve lung function while improving tolerability relative to historical oral pirfenidone.
Director, Global Regulatory Affairs CMC 3316 Takeda Development Center AmericasDirector, 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.
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.
Executive Director, Regulatory Affairs Dyne TherapeuticsExecutive Director, Regulatory AffairsWaltham, MA$250,000–$310,000 / yearThe 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. L everag e deep company knowledge to foster innovation, guide functional managers and leaders in embedding purpose, accountability, and emotional intelligence into operations, and model Dyne's values through leading with commitment and resolve .