Regulatory Projects Coordinator - Submissions & Timelines
Apex Systems
Apex Systems is looking for a Regulatory Project Coordinator for their biotech client in Cambridge, Massachusetts. This role will support regulatory submissions and project management while collaborating with teams using tools like SharePoint and OneNote. The ideal candidate will possess a BS degree, strong project management skills, and exceptional communication abilities. The supportive work environment promotes innovation and is focused on advancing programs for patients. #J-18808-Ljbffr Apex Systems
- Contractor, Regulatory Project Coordinator Our Cambridge based biotech client is seeking a regulatory project coordinator to join their... ...functional project management activities, maintain timelines, coordinate submissions, and help prepare teams for key health authority...RegulatoryFor contractorsRemote work
- ...Jennifer Wachen, Ph.D.), the Project Coordinator will oversee a randomized... ...procedures and systems, including regulatory requirements, coordination... ...IRB applications: initial submission, continuing review... ...of work, deliverables, and timelines as described. Collaborate...RegulatoryWork at officeLocal areaVisa sponsorshipWork visa
- ...medical device client is seeking a Senior Project Coordinator to support critical system separation... ...leadership across Quality, R&D, and Regulatory Affairs, ensuring alignment,... ...manage cross-functional dependency maps, timelines, and readiness indicators. Track upstream...RegulatoryLocal areaShift work
- Stratacuity: Proven Scientific Placement in Cambridge is seeking a Regulatory Project Coordinator to support their mission‑driven biotech team. You’ll engage in project management activities, maintain timelines, and prepare for interactions with health authorities. The...RegulatoryRemote job
- ...TITLE Executive Director, Regulatory Operations and Submission Management DEPARTMENT... ...standards (eCTD/CTD), strong project/program leadership, and... ...technical requirements and timelines. Serve as the... ...system/process controls, and coordinating responses and CAPAs in partnership...Regulatory
- A biopharmaceutical company in Boston is seeking a Regulatory Affairs Specialist to coordinate the preparation of regulatory submission packages. The ideal candidate will have at least 8 years of experience in Regulatory Affairs, particularly with Small Molecule drugs,...Regulatory
- AVEO Pharmaceuticals is seeking an Executive Director of Regulatory Operations to lead global submission management and ensure compliance and quality across submissions. The role requires extensive experience in regulatory operations and managing high-performance teams....Regulatory
- ...Therapeutics, Inc is seeking an experienced regulatory affairs professional in Boston, MA. Responsibilities include coordinating regulatory workflows, compiling submissions to the FDA, and providing ongoing support to project teams. The ideal candidate holds a Bachelors...Regulatory
$177k - $278.08k
Takeda in Boston, MA, is looking for a Regulatory CMC Lead with extensive experience in biopharmaceuticals to develop regulatory strategies and manage global submissions. The ideal candidate possesses 10+ years in the field and strong leadership skills. This hybrid position...Regulatory- Join EY as a Senior Manager in the Life Sciences Regulatory Submissions practice, located in Boston. You will drive growth and be pivotal in establishing EY as a leader in the Regulatory Compliance sector. The role involves leading teams, building client relationships,...Regulatory
$177k - $278.08k
JobRx, Inc. is seeking a Regulatory Affairs professional in Boston, MA to manage regulatory CMC strategy for pharmaceutical products.... ...10+ years of experience with a strong focus on leading major submissions and ensuring regulatory compliance. This position offers a hybrid...Regulatory$91.5k - $134.2k
Ipsen Biopharmaceuticals Inc. is seeking a Document Specialist to support regulatory submissions by ensuring documents are high-quality and ready for submission. The role requires collaboration with teams and experience in document management within the pharmaceutical...Regulatory- Page Mechanical Group, Inc. is looking for an Executive Director of Regulatory Operations and Submission Management. This strategic role oversees the global regulatory processes ensuring high-quality submissions and compliance across the product lifecycle. The ideal candidate...Regulatory
- A biotechnology company in Boston is seeking a Regulatory Affairs professional to coordinate and prepare document packages for regulatory submissions. The role involves providing regulatory support, preparing technical documents, and ensuring compliance with FDA regulations...RegulatoryWork at office
$91.5k - $134.2k
Ipsen Innovation (SAS) seeks a Document Specialist in Cambridge, MA, to support Regulatory and submission teams in electronic regulatory submissions globally. The role involves ensuring documents are completed to high standards and mentoring authors on compliance with standard...Regulatory- ...team providing strategic, operational, and people leadership. This role involves developing clinical and regulatory documents and coordinating complex submissions. Applicants should have a Bachelor’s degree and over 5 years of relevant experience in the biotechnology or...Regulatory
- Ipsen Group is looking for an Executive Assistant/Project Coordinator in Cambridge (US) to provide high-quality administrative and operational... ...arrangements, expenses, and coordinate meetings for the US Regulatory Advertising and Promotion team. The ideal candidate has at...RegulatoryWork at office
- IPSEN in Cambridge, MA, is seeking an Executive Assistant and Project Coordinator to provide comprehensive administrative support. The... ...procurement processes, ensuring efficient operations for the Regulatory Advertising and Promotion and Field Medical teams. This role...Regulatory
- A global medical device company is seeking a Senior Project Coordinator in the Boston area to support system separation initiatives while... ...coordinating with director-level leadership in Quality, R&D, and Regulatory Affairs. The ideal candidate will have strong...Regulatory
- ...administrative support to implement the goals of various projects, develops plans and systems and coordinates the day to day activities in order to ensure... ...these areas. Acts as liaison with other department and regulatory agencies and consultants on analyses of financial,...Regulatory
- ...monitoring multiple medium to large-scale project activities, managing documentation, and... ...a highly motivated full‑time Project Coordinator to support translational clinical... ...Responsibilities will include project coordination, regulatory support, team communication, data and...RegulatoryFull timeTraineeship
- ...administrative support to implement the goals of various projects, develops plans and systems, and coordinates daily activities to ensure project deliverables and... ...work groups, clinical areas, other departments, regulatory agencies, and consultants to analyze financial,...RegulatoryFlexible hours
$51.28k - $64.1k
...following Research Programs and Projects duties: Supports the... ...Overview The Research Project Coordinator serves as the link between administrative... ...creating project plans and timelines related to research... ...the deadlines for abstract submissions and conference/seminar registrations...Work at office$85k - $110k
...Summary & Purpose of the PositionThe Executive Assistant and Project Coordinator provides high quality, comprehensive, and timely... ...seamless coordination and execution of activities across the US Regulatory Advertising and Promotion team and the US Field Medical team...RegulatoryHourly payContract workTemporary workWork at officeLocal areaRemote workFlexible hours- The Boston VA Research Institute, Inc. (BVARI) is seeking a Project Coordinator to oversee a randomized controlled trial aimed at... ...smooth operations, manage participant tracking, and adhere to regulatory requirements. Successful applicants will have a BA/BS with...Regulatory
- ...decision-making. The successful candidate will apply biostatistical methods and manage analyst teams, with responsibilities in regulatory submissions and data integration. Preferred qualifications include an advanced degree in Biostatistics or a related field and 3-5 years...Regulatory
$55.53k - $61.7k
Dormont Manufacturing Co is seeking a Regulatory Coordinator in Boston to oversee the regulatory requirements for clinical research projects. This role involves preparing submissions, maintaining regulatory files, and ensuring compliance with federal regulations. Ideal...Regulatory- ...Senior Regulatory Affairs Manager- REMOTE I'm looking for a senior manager, regulatory... ...This role includes driving global submission planning, coordination, and execution across multiple... ...health authorities Monitor regulatory timelines and ensure compliance with all...RegulatoryFull timeRemote work
$177k - $278.08k
Takeda is seeking a Director, Global Regulatory Lead Oncology to oversee regulatory activities for oncology programs in Boston, MA. This role involves managing FDA submissions and setting global regulatory strategies. Ideal candidates will have 8+ years of pharmaceutical...Regulatory$150k - $200k
...across drug development stages. The successful candidate will have over 7 years of medical writing experience and expertise in regulatory submissions. This hybrid role allows employees to work from Cambridge, Massachusetts. Responsibilities include leadership of writing...Regulatory
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