Senior Director, Global Regulatory Submissions & Operations
Meet Life Sciences
A leading biotechnology company in Boston is seeking a Senior Manager for Regulatory Affairs Operations. In this hybrid role, you will lead global regulatory submissions and collaborate across teams to ensure timely delivery of regulatory documents. The ideal candidate has 6+ years of regulatory affairs experience, strong skills in eCTD publishing, and works well in cross-functional settings. This position offers competitive compensation and the opportunity to contribute to innovative oncology therapies. #J-18808-Ljbffr Meet Life Sciences
- Senior Director, Global Regulatory Lead, GI & Inflammation About the role: The Global Regulatory Leads,... ...determining the impact on business operations and compliance programs Implement... ...preparing and managing regulatory submissions with minimal guidance Skilled in analyzing...OperationsSeniorFull timeLocal area
$208.2k - $327.14k
...Overview Head of Global Regulatory Affairs Operations, Compliance & Process Excellence (Senior Director) – role at BioSpace, as described in the job posting. The Plasma... ...business by overseeing all PDT regulatory submissions globally to ensure proper resourcing, planning...OperationsSeniorFull timeRemote workFlexible hours$275k - $315k
...strategic and experienced Senior Director of Regulatory Affairs to lead and execute... ...—from IND through BLA submission and approval. You will manage... ...ResponsibilitiesDevelop and execute integrated global regulatory strategies to... ..., Biostatistics, Clinical Operations, Medical Affairs, and...OperationsSeniorFull timeTemporary workWork at officeLocal area3 days per week$212k - $333.19k
...patients worldwide.Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will be... ...development stages. Provide strategic, operational and tactical regulatory insight on... ...manner.Accountable for US FDA submissions and approvals of project(s) of responsibility...SeniorMinimum wageTemporary workLocal areaRemote workWorldwide- ...will work closely with labeling operations, compliance teams, and various internal... ...Key Responsibilities Represent Global Labeling on product-specific Global Regulatory Teams and other cross-functional... ...and Supply Chain to ensure submission-ready labeling components comply...OperationsLocal area
- ...Reference26-00886 Job Description: This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices... ...that enables the development of robust and accurate submissions. Develops constructive relationships with and proactively communicates...Senior
$137k - $215.27k
...changing therapies to patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and... ...that enables the development of robust and accurate submissions.Develops constructive relationships with and proactively communicates...SeniorMinimum wageTemporary workLocal areaRemote workWorldwide- ...Pharmaceuticals, Inc. is seeking an experienced Regulatory CMC professional to execute high-... ...contributor role collaborates with Global Regulatory Affairs, Technical Operations, and Quality to ensure timely, complete submissions and alignment with global requirements....OperationsSenior
$245k - $300k
...an experienced and strategic Senior Director, Regulatory Affairs to lead and execute global regulatory strategies across our... ...Pharmacology, Clinical Operations, Biostatistics, Pharmacovigilance... ...guidance on regulatory pathways, submission strategies, expedited programs...OperationsSeniorLocal area- ...pharmaceutical 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... ...vital for supporting ongoing global clinical studies. #J-18808-Ljbffr...
- Relay Therapeutics in Cambridge, MA is seeking a motivated regulatory professional to join their dynamic team. You will support innovative regulatory strategies and manage global submissions including IND, CTA, NDA, and MAA. The ideal candidate has a B.S./M.S. with 2+ years...
- ...United States is seeking an experienced Associate Director / Director of Regulatory Affairs to lead global regulatory activities and ensure compliance with applicable... ...influence regulatory strategy, prepare and manage submissions, and navigate complex regulatory landscapes. Ideal...
- ...YouTube. Job Description The Senior Manager, Regulatory Affairs US & Canada... ...and supports manager and/or Global Regulatory Lead (GRL) in the... ...on business activities and operations. Serves as Health... ...and review of regulatory submissions consistent within US and Canada...OperationsSeniorLocal area
- A biotechnology company in Cambridge, MA is looking for a Senior Director of Biostatistics to lead statistical activities for clinical programs, provide input during regulatory submissions, and mentor junior statisticians. This role demands expertise in statistical analysis...Senior
$137k - $165k
Overview The Senior Manager, Global Trade Compliance - Export Compliance is a... ...In partnership with the Sr. Director of Global Trade Compliance,... ..., and ensure adherence to regulatory requirements across all jurisdictions... ...in which the company operates. The role requires deep...OperationsSeniorFull timeTemporary workPart timeWork at officeLocal area- ...Flexibility: RemoteWhat you will doThe Senior Manager, Compliance PMO is... ...management office across the global Compliance department to... ...as the organization and its operations; provide strategic input on... ...Internal Audit, Risk Management, Regulatory/Quality, or Operations...OperationsSeniorFull timeTemporary workFor contractorsRemote work
- ...experience in legal, regulatory, compliance environments... ...relationships with senior leaders within and outside... ...with ability to drive global projects to outcomes,... ...strategic and operational initiatives to deliver... ...Your role reports to the Director of Ethics in Allegations...OperationsSeniorApprenticeshipWork at office
$167k - $300.7k
...Moderna, Inc. is seeking a Director of Regulatory Strategy to support select... ...a strategic leader within Global Regulatory Science, responsible... ...Development Team and senior management, as relevant.Collaborates... ...content and management of submissions to Health Agencies.Sets...Permanent employmentFull timeWork at officeWork from home$218.06k - $327.09k
Job Title: Senior Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg... ...to role: Are you ready to set the global regulatory vision for pioneering cell... ...program, from current stage through BLA submission, ensuring an efficient route to...SeniorHourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per week$232k - $348k
Job DescriptionThe Regulatory Strategy Senior Director is a regulatory leader with expert... ...for the assigned global or regional position and... ...regulatory, scientific, operational and business knowledge into... ...including for regulatory submission documents and Health Authority...SeniorFull timeSummer workWork at officeLocal areaRemote workFlexible hours2 days per week3 days per week$182k - $275k
Company OverviewRhythm is a global, commercial-stage biopharmaceutical... ...-based, and compliant regulatory CMC deliverables for... ...Regulatory Affairs and Technical Operations.This individual contributor... ...CMC regulatory documents and submissions, including core dossiers, INDs...OperationsWork at office$209.35k - $258.6k
Regulatory AffairsCambridge, MA • ID: 26... ...?Job Summary:The Director, Regulatory Affairs... ...& executing global labeling strategy... ...alignment across senior cross-functional... ...Product Labeling (SPL) submissions and compliance... ...supporting labeling operations and systemsEnsure...OperationsFull timeWork at officeLocal areaRelocationFlexible hours- Senior Finance & Operations Manager - J-PAL Global The Abdul Latif Jameel Poverty Action Lab (J-PAL) is an anti-poverty... ...grant opportunities; Manage the submission of grant proposals into MIT’s... ...Supervise donor reporting; With the Director of Finance and Operations and other...OperationsSeniorFull timeWork at officeWorldwide2 days per week
$180k - $245k
...Therapeutics is seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our development programs... ...regulatory expectations.Lead the preparation, submission, and maintenance of regulatory applications, including...$200k - $220k
...Director/ Senior Director, Regulatory CMC Join Us in Tackling Autoimmune Disease at Its Root At Vor, we believe... ..., through clinical development and global registration. The candidate must be... ...execute high‑quality CMC related submissions including INDs/CTAs or amendments...SeniorContract workWorldwideFlexible hours$220k - $290k
...the U.S. and are exploring regulatory pathways for Europe and Japan... ...short and long‑term plans. The Senior Director, Regulatory Affairs has... ...Develop, update and implement a global regulatory strategy which... ...staff in the preparation and submission of applications and routine...SeniorTemporary workFor contractorsWork at officeWeekday work- ...Alnylam continues to expand its global development and regulatory footprint, Regulatory Sciences... ...data quality, compliance, and operational efficiency.The Director, Regulatory Sciences Technology... ...improve compliance, efficiency, and submission quality.· Lead the delivery,...OperationsFull timeTemporary workLocal areaFlexible hours
$150k - $195k
...understanding of their bodies and daily lives.WHOOP is hiring a Senior Global Supply Manager, Electromechanical to lead the sourcing... ...products. In this role, you will partner closely with Engineering, Operations, Manufacturing, Quality, and suppliers to bring innovative...OperationsSeniorFull timeWork at officeRelocationOverseas- Massachusetts Institute of Technology (MIT) — through J-PAL — seeks a Senior Finance and Operations Manager to lead financial operations and grants management... ...financial operations, budgeting, and governance in a global nonprofit research context, with collaboration across...OperationsSenior
- ...looking for a detail-oriented Accountant to join their new finance and operations hub in Boston. This role will manage daily accounting operations and support financial reporting, coordinating with global teams. The ideal candidate will have 3-5 years of experience, a...OperationsSenior
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