NewAssociate Director/Director, CMC Regulatory Relay Therapeutics, Inc.Associate Director/Director, CMC RegulatoryCambridge, MA$143,000–$233,000 / 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 PharmDev and Regulatory Affairs Teams, as appropriate. Built on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology.
Associate Director, Regulatory Strategy Alpha-9 Oncology, Inc.Associate Director, Regulatory StrategyBoston, MAReporting to the Vice President, Regulatory Affairs, this individual will help shape and execute global regulatory strategy, lead submission planning and execution, and support interactions with health authorities across our programs. This is a hands-on role with the opportunity to work closely with leadership and cross-functional teams while helping build the processes and capabilities that will support the continued growth of the Regulatory Affairs function.
Senior Manager, Strategy - Medical Affairs Azurity Pharmaceuticals IncSenior Manager, Strategy - Medical AffairsWoburn, MARemoteMedical Affairs at Azurity Pharmaceuticals, a privately held company delivering innovative medicines for overlooked patients across 50+ countries, drives scientific and clinical initiatives with a portfolio of 30+ brands spanning 10 dosage forms and 9 therapeutic areas. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline.
Senior Director, Regulatory Affairs Bicara Therapeutics IncSenior Director, Regulatory AffairsBoston, MAFICERA 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.
NewUSA - Associate Director Global Regulatory Affairs eTeam Inc.USA - Associate Director Global Regulatory AffairsCambridge, MAThe Global Regulatory Labeling Strategy Lead (Associate Director), Plasma-Derived Therapies Business Unit (PDT BU) is a key role in Global Labeling and works under the direction of the Head of Global Labeling and is: Responsible, with minimal supervision for providing regulatory expertise, strategic insight, and guidance to internal stakeholders, including Clinical, Pharmacovigilance, Legal, Scientific, Commercial, to ensure successful development and maintenance of labeling managed within. Ensuring that there is strategic labeling input in the implementation of regulatory strategies and liaises with regulatory team members in evolving submission and negotiation plans.
Senior Director, Regulatory Strategy & Policy GaldermaSenior Director, Regulatory Strategy & PolicyBoston, District of Columbia$240,000–$320,000 / yearServes as the U.S. FDA Regulatory Affairs strategic partner to the Global Heads of Regulatory Strategy (Therapeutic Dermatology, DS and IA), providing strategic leadership on FDA engagement, regulatory submissions, and Health Authority interactions to ensure alignment of U.S. regulatory strategy with global development objectives and successful product development and lifecycle management. Represents Global Regulatory Affairs (GRA) on core development and cross-functional project teams, collaborating with regional and global leaders to ensure a unified regulatory approach that supports FDA interactions and global commercial strategy.
Senior Regulatory Affairs Specialist Boston Scientific CorpSenior Regulatory Affairs SpecialistMarlborough, 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. Your responsibilities will include: Reviews change notifications and performs regulatory impact assessment for product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings, and supports associated global submissions as needed.
Regulatory & Clinical Specialist LivaNovaRegulatory & 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.
Director, Regulatory Advertising And Promotion bluebird bio, Inc.Director, Regulatory Advertising And PromotionSomerville, MA$185,000–$285,000 / yearThe 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.
Associate Director, Clinical Scientist CRISPR TherapeuticsAssociate Director, Clinical ScientistSouth 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. The Company continues to expand its leadership in gene editing through the development of SyNTase editing, a novel and proprietary gene-editing platform designed to enable precise, efficient, and scalable gene correction.
Vice President, Clinical and Scientific Affairs Boston Scientific CorpVice President, Clinical and Scientific AffairsMarlborough, MAThe successful candidate will be responsible for working cross-functionally to help product teams generate evidence strategies for products within the Endoscopy portfolio and oversee the design, execution, and interpretation of evidence generation efforts including sponsored clinical trials, investigator sponsored research, cooperative clinical research, and the use of real-world evidence. Partner with the Endoscopy Chief Medical Officer to build and maintain relationships with external Key Opinion Leaders, academic institutions, and professional societies to enhance the organizations scientific credibility and reputation, and to provide meaningful insights into Endoscopy's clinical research strategies.
Senior Manager, R&D Data, Data Science, And AI - Digital Health For Neuropsychiatry Johnson & JohnsonSenior Manager, R&D Data, Data Science, And AI - Digital Health For NeuropsychiatryCambridge, MARemote$137,000–$235,750 / yearDigital Endpoints & Tools: Execute the neuropsychiatry-focused digital health strategy by applying AI/ML, modeling, and longitudinal analytics to support patient stratification, endpoint development, and clinical trial optimization, in partnership with disease experts, statisticians, and platforms and clinical teams on study design and validation of digital measures, balancing their informativeness with low clinical burden for patients and study teams. All Job Posting Locations: Cambridge, Massachusetts, United States of America, Raritan, New Jersey, United States of America, San Diego, California, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America.
Vice President, Quality Control Candel Therapeutics IncVice President, Quality ControlNeedham, MA$290,000–$335,000 / yearThe Vice President, Quality Control will provide strategic, technical, and operational leadership for all Quality Control functions supporting the development, manufacture, release, and lifecycle management of viral vector and advanced therapy products. This role will work closely with CMC leadership, Analytical Development, Process Development, Manufacturing, Quality Assurance, Regulatory Affairs, Clinical Development, Supply Chain, Program Management, external laboratories (CROs/CDMOs), and executive leadership.
Medical Director - Hematology Treeline Biosciences IncMedical Director - HematologyWatertown, MA$302,276–$370,530 / yearWorking collaboratively across Clinical Development, Clinical Operations, Safety, Biometrics, Regulatory Affairs, and external partners, the Medical Director helps ensure studies are conducted efficiently while maintaining scientific integrity and patient safety. Unsolicited resumes sent to Treeline Biosciences from recruiters do not constitute any type of relationship between the recruiter and Treeline Biosciences and do not obligate Treeline Biosciences in any way to pay fees should we hire from those resumes.
Global Medical Affairs Operations Manager MedelaGlobal Medical Affairs Operations ManagerBoston, MAThis role is a critical connector across Medical Affairs, Clinical, Sales, Marketing, and external healthcare partners to ensure successful delivery of scientific and educational programs that improve outcomes in maternity and neonatal care. This person will lead the execution of global Medical Affairs programs, educational initiatives, and real-world evidence activities supporting healthcare professionals and customers worldwide.
Senior Manager, R&D Data, Data Science, and AI - Digital Health for Neuropsychiatry Johnson & JohnsonSenior Manager, R&D Data, Data Science, and AI - Digital Health for NeuropsychiatryCambridge, MARemote$137,000–$235,750 / yearDigital Endpoints & Tools: Execute the neuropsychiatry-focused digital health strategy by applying AI/ML, modeling, and longitudinal analytics to support patient stratification, endpoint development, and clinical trial optimization, in partnership with disease experts, statisticians, and platforms and clinical teams on study design and validation of digital measures, balancing their informativeness with low clinical burden for patients and study teams. All Job Posting Locations: Cambridge, Massachusetts, United States of America, Raritan, New Jersey, United States of America, San Diego, California, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America.
NewAssociate Director, Medical & Scientific Communications Alkermes PlcAssociate Director, Medical & Scientific CommunicationsWaltham, MARemoteIn 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.
Senior Director, Regulatory Strategy Vertex Pharmaceuticals, IncSenior Director, Regulatory StrategyBoston, MA$232,000–$348,000 / yearThe 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.
Biosample Operations Associate Oruka TherapeuticsBiosample Operations AssociateWaltham, CaliforniaRemoteThis role serves as the primary liaison between investigative sites, central laboratories, specialty testing laboratories, clinical operations, and study vendors to ensure the accurate tracking, transfer, reconciliation, and documentation of clinical trial samples. The Biosample Operations Associate/Senior Associate oversees chain-of-custody processes and sample logistics from collection at clinical sites through shipment to central laboratories and onward transfer to specialty or third-party testing laboratories.
Associate Director, Marketing - Romvimza Deciphera Pharmaceuticals IncAssociate Director, Marketing - RomvimzaWaltham, MA$174,000–$239,000 / 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.