Manger, Transplant Quality & Regulatory Compliance Beth Israel Lahey HealthManger, Transplant Quality & Regulatory ComplianceBoston, MassachusettsActual compensation is determined based on several factors, that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other applicable factors permissible by law. $120,000.00 USD - $150,000.00 USD The pay range listed for this position is the annual base salary range the organization reasonably and in good faith expects to pay for this position at this time.
Regulatory Specialist for Center for Anesthesia Research Excellence Beth Israel Lahey HealthRegulatory Specialist for Center for Anesthesia Research ExcellenceBoston, MassachusettsCustomer Service: Ability to provide a high level of customer service to patients, visitors, staff and external customers in a professional, service-oriented, respectful manner using skills in active listening and problem solving. Prepare and submit applications (industry, cooperative groups and PI initiated studies), respond to IRB comments on applications submitted and work with study team in getting studies activated for enrollment of patients.
Principal Customer Solutions Architect, Ads Regulatory Compliance MicrosoftPrincipal Customer Solutions Architect, Ads Regulatory ComplianceBoston, MA$142,800–$274,800 / yearAs the Principal Customer Solutions Architect, Ads Regulatory Compliance, you will operate at the intersection of product, engineering, policy, legal, operations, and business strategy to translate emerging regulatory requirements into scalable frameworks, governance models, and solution architectures. There is a different range applicable to specific work locations, within the San Francisco Bay area and New York City metropolitan area, and the base pay range for this role in those locations is USD $188,000 - $304,200 per year.
Head Of Regulatory Examinations Management, MD State Street CorporationHead Of Regulatory Examinations Management, MDBoston, MA$170,000–$267,500 / yearThe Global Head of Regulatory Examination Management is a senior leadership role within the Global Regulatory Liaison Office (GRLO) responsible for leading the firm's global regulatory examination program, including the governance, coordination, and execution of supervisory reviews across jurisdictions. Our GRLO serves as the primary liaison with regulators in jurisdictions in which we operate and is responsible for strategically managing those relationships through a global operating model that supports local, regional and global needs consistently.
Senior Director, Regulatory Strategy Vertex PharmaceuticalsSenior Director, Regulatory StrategyBoston, MassachusettsThe Regulatory Strategy Senior Director is a regulatory leader with expert technical and tactical experience in regulatory strategy for the assigned global or regional position and will be responsible for overseeing the development and implementation of advanced global regulatory strategies for development programs (1) in emerging disease areas, (2) for additional development of registered Vertex medicines, and/or (3) for the support of Vertex marketed products. Demonstrates excellent communication skills with ability to impact and influence the decisions of a team, communicates with all levels within the company and act as liaison / representative both internally and externally and communicates effectively in verbal presentations and in writing regulatory strategy plans and submission documents.
Sr. Director, Regulatory CMC Genetix BiotherapeuticsSr. Director, Regulatory CMCSomerville, MassachusettsThe Senior Director serves as a key regulatory partner to Technical Operations, Quality, and Supply Chain, and acts as the primary CMC regulatory interface with global health authorities for post-approval activities, including supplements, variations, annual reports, and inspection support. The Senior Director, Regulatory CMC is responsible for defining and executing global CMC regulatory strategy for approved and late-stage gene therapy products, with a strong emphasis on lifecycle management, change management, and sustained regulatory compliance.
RA Specialist II Job Details | Olympus Corporation Of The Americas OlympusRA Specialist II Job Details | Olympus Corporation Of The AmericasWestborough, MAOlympus 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. Where designated, interface with International Regulatory Affairs Team to support preparation of dossiers for registration for other international markets such as Japan the Far East Australia and Latin America.
Director, Regulatory CMC Genetix BiotherapeuticsDirector, Regulatory CMCSomerville, Massachusetts$204,000–$245,000 / yearThe Director, Regulatory CMC is responsible for leading execution of global CMC regulatory strategies for approved and late-stage gene therapy products, with a primary focus on lifecycle management, change management, and regulatory compliance. This role supports the development and delivery of post-approval regulatory strategies and ensures effective implementation of manufacturing, analytical, and control changes across global markets.
Associate Director, Nonclinical Development Program Management & Strategic Operations (Late-Stage Development) Vertex PharmaceuticalsAssociate Director, Nonclinical Development Program Management & Strategic Operations (Late-Stage Development)Boston, MassachusettsWorking closely with Project Leaders, functional subject matter experts, Regulatory Affairs, and external partners, this individual develops and maintains integrated project and submission plans to ensure key development and regulatory milestones are achieved on time and within budget. The Associate Director, Nonclinical Sciences Program Management & Strategic Operations (PMSO) is responsible for the integration, planning, coordination, and execution of complex pharmaceutical development programs across the nonclinical development lifecycle.
NewDirector, Regulatory Advertising and Promotion Genetix BiotherapeuticsDirector, Regulatory Advertising and PromotionSomerville, MassachusettsThe Director serves as a key regulatory partner to Medical Affairs, Commercial, Marketing, and Legal, and plays a central role in promotional material review in a highly regulated environment, for cell and gene therapy products. Actual base salary pay will be based on several factors, including but not limited to experience, skills, relevant education/qualifications, external market, internal equity, and other job-related factors permitted by law.
NewDirector, Global Regulatory Labeling Strategy 3316 Takeda Development Center AmericasDirector, Global Regulatory Labeling StrategyMassachusettsRemoteConducts precedent searches, analyzes relevant competitor labeling, health authority labeling requests for Takeda products, labeling guidance and trends; and develops strategies and labeling language for inclusion assigned product labels (TLP, CCDS, USPI, EU SmPC, others as appropriate) to ensure consistency with the overall product strategy, product claims and information in the CCDS and to ensure that Takeda products have the most competitive labeling possible; while maintaining awareness of recent in-class approvals. In alignment with TAU/MPD Labeling Lead, coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee - GLOC) providing leadership to foster cross-functional collaboration and drive alignment of the labeling strategy and labeling content at all levels.
NewDirector, Global Regulatory Lead - Oncology 3316 Takeda Development Center AmericasDirector, Global Regulatory Lead - OncologyBoston, MassachusettsStrong and independent skills in regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.
NewDirector or Senior Director, Regulatory CMC Kymera TherapeuticsDirector or Senior Director, Regulatory CMCWatertown, MA$195,000–$330,000 / yearHaving advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Lead the development and execution of global regulatory CMC strategies for degrader programs across all stages of development, from early-stage activities through late-stage development and approval with specific emphasis on late-stage activities.
Associate Director / Director, Medical Information Cognito TherapeuticsAssociate Director / Director, Medical InformationCambridge, MAPartner closely with Medical Affairs, Field Medical, Scientific Communications, Clinical Development, Pharmacovigilance/Drug Safety, Quality, Commercial, Market Access, Patient Support, and other functions to support compliant scientific exchange and launch readiness. Serve as the internal subject matter expert on MI best practices, regulatory expectations (FDA, EMA/MDR/Notified Bodies), and industry benchmarks for neurocognitive disease and advanced therapies.
Senior Director, Product Quality Lead (Post-Marketing and Pharmacovigilance Madrigal PharmaceuticalsSenior Director, Product Quality Lead (Post-Marketing and PharmacovigilanceWaltham, MassachusettsAs a key member of the Quality leadership team, you will partner closely with Pharmacovigilance, Regulatory Affairs, Manufacturing, and Commercial teams to embed quality across the full product lifecycle, with particular focus on post-marketing safety surveillance, literature monitoring, and Product Quality Complaints (PQC). Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality.
Medical Science Liaison / Senior Medical Science Liaison - COVID/Virology - New England Shionogi Inc.Medical Science Liaison / Senior Medical Science Liaison - COVID/Virology - New EnglandBoston, Massachusetts$175,000–$220,000 / yearPrevious MSL experience in the pharmaceutical/biopharmaceutical industry required with previous respiratory infectious disease experience preferred; experience in COVID-19 preferred OR , previous MSL experience in the pharmaceutical/biopharmaceutical industry preferred with previous respiratory infectious disease experience required. Overview: The Medical Science Liaison (MSL)/Senior Medical Science Liaison (Sr MSL) is a field-based representative of the Medical Affairs Organization that supports and represents Shionogi Inc and its products with, and to, key opinion leaders (KOLs), clinicians, institutions, and professional organizations.
NewVice President, Pharmacovigilance Deciphera Pharmaceuticals IncVice President, PharmacovigilanceWaltham, MA$335,000–$460,000 / yearROMVIMZA (vimseltinib) is a kinase inhibitor approved in the United States for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity, and in the European Union for adult patients with TGCT associated with clinically relevant physical function deterioration and in whom surgical options have been exhausted or would induce unacceptable morbidity or disability. In addition to advancing multiple product candidates from Deciphera's platform in clinical studies, QINLOCK (ripretinib) is Deciphera's switch-control kinase inhibitor approved in many countries including the European Union and the United States for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.
Vice President, Biometrics City TherapeuticsVice President, BiometricsCambridge, MassachusettsThe Vice President, Biometrics will serve as the senior leader responsible for biometrics activities at City Therapeutics, encompassing biostatistics, and statistical programming, This individual will report to CMO and be a key strategic partner to Clinical Development, Clinical Operation, Regulatory Affairs, and Medical Affairs — driving the design, execution, analysis, and reporting of clinical trials across the portfolio. This role requires both deep technical expertise and the leadership acumen to influence enterprise-level development decisions, lead related regulatory interactions, and build a high-performing team in a fast-growing organization.
Associate Director, GMP Operational Quality (Biologics And Devices) Vertex Pharmaceuticals, IncAssociate Director, GMP Operational Quality (Biologics And Devices)Boston, MA$94,600–$141,800 / yearThe successful candidate will be a key member of the Vertex Biologics and Devices Quality Team, influencing cross-functional alignment, proactively managing risk, and providing timely quality direction in support of external drug substance manufacturing and disposition. Key Duties and Responsibilities: Lead cross-functional collaboration with Manufacturing, Quality Control, MSAT, Regulatory Affairs, and other Quality functions to resolve complex deviations and align decisions with patient safety, product quality, and regulatory compliance.
Medical Writer Clinical Development Sunrise Systems IncMedical Writer Clinical DevelopmentMarlborough, MARemote$100–$112 / hourCollaborate with cross-functional teams, including Clinical Development, Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, Pharmacovigilance, and Medical Affairs, to gather, interpret, and integrate scientific and clinical information into clear, accurate, and submission-ready documents. This role works closely with cross-functional stakeholders to ensure documents are scientifically accurate, strategically aligned, and delivered according to established timelines and medical writing plans.