Global Regulatory Operations Exec Submissions & Systems
Aveo Pharmaceuticals Inc
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. The ideal candidate will oversee submission processes, implement regulatory systems, and maintain current knowledge of global regulations, while working cross-functionally to achieve operational excellence. #J-18808-Ljbffr
- ...Monte Rosa Therapeutics is seeking a Regulatory Operations Manager in Boston, MA. This role demands... ...operations with proficiency in eCTD submissions and vendor oversight. The candidate will... ...databases, maintain compliance with global standards, and prepare submission-ready...OperationsRegulatory
- ...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...OperationsRegulatory
- ...AVEO Oncology is seeking an Executive Director for Regulatory Operations. This role involves providing strategic leadership for global regulatory operations, ensuring compliance and submission quality across the product lifecycle. The successful candidate will establish...OperationsRegulatory
$122.25k - $176.58k
...Job title: Global Submission Lead Location: Morristown, NJ / Cambridge,... ...coordination, and tracking of regulatory Priority portfolio and... ...continuous evaluation to drive operational effectiveness for... ...development and integrity of GRO systems and procedures. Lead and/or...OperationsRegulatoryWorldwideFlexible hours- ...Job title: Global Regulatory Strategist Location: Morristown, NJ/ Cambridge, MA About the... ...Our deep understanding of the immune system – and innovative pipeline – enables... ...within remit, as needed Regulatory Submissions & Operations Leads submission teams or regulatory...OperationsRegulatoryLocal area
- ...Mass Digital Health is seeking a Global Submission Lead in Cambridge, MA, or Morristown, NJ. This role focuses on planning, coordination, and execution of regulatory submission activities within the R&D team at Sanofi. The ideal candidate will have over 5 years of experience...OperationsRegulatory
- Scholar Rock is a late-stage global biopharmaceutical company focused... ...Director of Quality Systems and GxP Compliance. Reporting... ...aspects of quality systems and regulatory compliance across commercial,... ...transition from clinical-stage operations to a commercial-ready, scalable...OperationsRegulatory
$160k - $196k
...Associate Director, Regulatory Operations Global Submission Management page is loaded## Associate Director, Regulatory Operations Global Submission Managementlocations... ...RFIs).* Strong understanding of regulatory operations systems (RIMS, EDMS, publishing platforms).* Demonstrated...OperationsRegulatoryMinimum wageFull timeLocal areaRemote workFlexible hours- ...Rock is looking for a Director of Quality Systems and GxP Compliance in Cambridge, MA.... ...leadership role overseeing quality systems and regulatory compliance across commercial, clinical,... ...initiatives to prepare for commercial operations while supporting compliance and...OperationsRegulatory
- ...Job Title Executive Director, Regulatory Operations and Submission Management Department Regulatory Affairs Reports To Head of Regulatory... ...strategic and operational leadership for global regulatory operations and systems, submission management and execution across the...OperationsRegulatory
$136k - $170k
...muscle, central nervous system, and cardiac diseases.... ...The Senior Manager, Regulatory Information Management... ...and tracking. Provide submission management support and... ...system enhancements. Operate under medium to low supervision... ...software, and global regulatory guidelines....OperationsRegulatoryWork at office- ...Are you ready to lead global cell therapy programs... ...Senior Global Clinical Operations Program Director, you... ...turning bold ideas into regulatory-ready results? This is... ...of regulatory submissions, support regulatory interactions... ...in business reporting systems such as PLANIT....OperationsRegulatoryContract workWork experience placement
- ...and oversight of the global PV compliance program... ...with applicable global regulatory requirements, industry... ...-functionally with PV Operations, Clinical Safety, Regulatory... ...across the PV system. Position Responsibilities... ..., and regulatory submission compliance, as applicable...OperationsRegulatoryLocal area
$136k - $170k
...Senior Manager, Regulatory Information Management System (RIMS) The promise of genetic medicine... ...used to develop regulatory submissions for dispatch to health authorities globally. The Senior Manager, RIM... ...hoc system enhancements Operate under medium to low supervision...OperationsRegulatoryWork at office$232.5k - $335.83k
...Global Head of Clinical Data and Business Strategy Location:... ...within Clinical Sciences and Operations. The Global Head of... ...clinical databases supporting regulatory submissions. We seek an exceptional leader... ...Clinical Data Technology, Systems/Tools/Processes, and Business...OperationsRegulatory$150k - $200k
Medical Writing Lead, Global Clinical Operations, Orion Pharma Cambridge, United Kingdom and 3 more... ...of drug development and global regulatory submissions, ensuring quality and compliance through... ...with document management systems. Preferred Experience in small biotech...OperationsRegulatoryWorldwide- ...company is looking for a Director of Regulatory Affairs to provide strategic and operational leadership in developing and... ...will prepare regulatory submissions, interact with health authorities... ...is vital for supporting ongoing global clinical studies. #J-18808-Ljbffr...Regulatory
$331.87k
...of person. We are hiring a Global Clinical Head (GCH) for Obesity... ...closely with the Clinical Operations lead and ensure the CPT... ...implements new processes, systems and learning Perform medical... ...plans. Experience with global regulatory submissions and interacting with major...OperationsRegulatoryTemporary workWork at officeLocal areaWorldwideFlexible hours3 days per week- ...Xenon Pharmaceuticals Inc. is seeking a Senior Manager for Regulatory Affairs Operations at its Needham, MA office. This role involves supporting global regulatory submissions through effective collaboration with cross-functional teams. Ideal candidates will have over...OperationsRegulatoryWork at office
$154.4k - $242.55k
...future for the world. As a global, values‑based... ...that affect immediate operations, disciplines, or other... ...production of underwriting submissions and support any market... ...challenges and/or regulatory issues; recommend process... ...management information systems to streamline...OperationsRegulatoryMinimum wageFull timeContract workTemporary workWork at officeLocal areaImmediate start- ...function Clinical Sciences & Operations (CSO) - plays a vital... ...clinical trial submissions and project operations... ...responsible for orchestrating global-scale digital and AI... ...technology and regulatory constraints into strategic... ...of the immune system and innovative pipeline...OperationsRegulatoryWork at officeShift work
$275k - $325k
...is seeking a Corporate Controller in Waltham, MA to lead global accounting operations. The ideal candidate will have 15+ years of experience and... ...leading accounting functions, ensuring compliance with regulatory requirements, and driving process improvements. The position...OperationsRegulatory$160k - $196k
...A biopharmaceutical company is seeking an Associate Director of Regulatory Operations to lead regulatory submissions. The role requires collaboration across teams to ensure compliance and excellence, with responsibilities including planning complex submissions and maintaining...OperationsRegulatoryFlexible hours$155k - $190k
...Nova Biomedical: One Global Brand. One Vision. Together... ...The Principal Systems Engineer is responsible... ...designs that meet clinical, regulatory, and business needs.... ..., and regulatory submissions by providing system rationale... ...safe, reliable operation across clinical, home,...OperationsRegulatoryHourly payWork at officeFlexible hours- ...Drug Product team. This role involves overseeing analytical development, managing budgets, and ensuring compliance with global regulatory submissions. The ideal candidate will hold a Ph.D. with over 10 years of experience in pharma/biotech and possess expertise in combination...OperationsRegulatory
- ...Delhaize USA, a division of global food retailer Ahold Delhaize,... ...Technology and more. The Business Systems Analyst IV is a senior... ...solutions that support Retail Operations, Payments, and Finance. This... ...Support audit, compliance, and regulatory activities (e.g., PCI), including...OperationsRegulatoryFull timeFlexible hours
- ...Vice President, Global Quality Compliance About the Company... ...for providing enterprise-wide regulatory compliance oversight, with a... ...central authority on quality systems, ensuring regulatory alignment... ...Percent Less than 10% Functions ~ Operations ConfidentialOperationsRegulatory
- ...best. As part of the Global Medical Affairs Oncology... ..., NCCN or pathway submissions, animations, and digital... ...optimize publications systems for reporting metrics... ...collaboration with GMAO Operations team As needed, provide... ...Compliance and Regulatory: Excellent understanding...OperationsRegulatoryFor contractorsWork experience placementFreelanceLocal area
- ...best. As part of the Global Medical Affairs Oncology... ..., NCCN or pathway submissions, animations, digital amplification... ...optimize publications systems for reporting metrics.... ...with GMAO Operations team. Provide medical... ...planning. Compliance and Regulatory - excellent...OperationsRegulatoryFor contractorsWork experience placementFreelanceLocal area
- ...patients worldwide.Join Takeda as Director, Global Regulatory Labeling Strategy where you will be... ....Labeling Documents Authoring, Submission, and Labeling Negotiations Independently... ...Regulatory Team (GRT)Liaises with US Labeling Operations, EU Labeling Operations, Labeling...OperationsRegulatoryLocal areaImmediate startWorldwide
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