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
$195k - $330k
...an impact:Act as the global regulatory strategy lead for Kymera... ...to program teams and senior leadership.Manage and... ...programs or business operations.Contribute to... ...preferred but not required.Director: 8-10 years of... ...marketing application submission and approvalDemonstrated...OperationsSeniorFlexible 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$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-Derived... ...business by overseeing all PDT regulatory submissions globally to ensure proper resourcing,...OperationsSeniorFull timeRemote workFlexible hours$196.7k - $353.4k
...to lead development and execution of global regulatory strategy for programs in its oncology... ...convention, delivering with excellence, and operating as an enterprise leader. The... ...through commercializationDrive regulatory submissions (INDs, CTAs, BLAs/MAAs) with excellence...SeniorPermanent employmentFull timeWork at officeWork from home- Senior Manager - Regulatory Affairs Operations Location - Cambridge, MA (Hybrid) Oncology Biotech | Global Clinical Programs I’m currently supporting an... ...increasing number of regulatory submissions and interactions with... ...Reporting into the Director of Regulatory Affairs...OperationsSenior
$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- Scorpion Therapeutics in Boston seeks a Senior Global Regulatory Leader to drive regulatory strategy across oncology programs from discovery... ...timelines and accelerate patient access. You will manage US FDA submissions (NDA/BLA/MAA) and liaise with global regulators, while...Senior
$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...SeniorPermanent employmentWork at officeWork from home- ...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
- ...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
$259k - $317k
...Position Summary: The Senior Director of Regulatory Affairs is a senior leader... ...developing and executing global regulatory strategy across... ...and execution of IND/CTA submissions and amendments; oversee clinical... ...with Regulatory Operations Build, mentor, and retain...OperationsSeniorFull timeWork at officeFlexible hours$245k - $300k
...Description Description: Sr. Director, Regulatory Affairs At... ...and strategic Senior Director, Regulatory... ...to lead and execute global regulatory strategies... ...Pharmacology, Clinical Operations, Biostatistics, Pharmacovigilance... ...regulatory pathways, submission strategies, expedited...OperationsSeniorLocal area$190k - $210k
...access a $15 billion global market opportunity.... ...the Role Associate Director, Global Regulatory Affairs, Compliance... ...Compliance, reporting to the Senior Director, Global... ...‑quality regulatory submissions—including INDs, NDAs... ...and compliant operations Provide regulatory...OperationsWork at officeFlexible hours2 days per week- Parabilis Medicines is seeking a Senior Manager/Associate Director, Regulatory Operations to lead global regulatory submissions, information management, and publishing initiatives. You will drive Veeva RIM implementations and collaborate across Regulatory Affairs, Medical...OperationsSenior
- ...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...
- ...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...
- Treeline Biosciences in Watertown, MA is seeking an experienced Associate Director / Director of Regulatory Affairs to lead global regulatory activities, shape strategy, and manage submissions across INDs, NDAs, and BLAs. The role requires 8+ years in regulatory affairs...
- ...Moderna Therapeutics is seeking a Sr. Director of Regulatory Strategy to support oncology programs... ...on to articulate clear and compelling global regulatory strategies, highlighting risks... ...and accountability for regulatory submissions and related supplements and amendments...SeniorWork from home
- ...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
$12.08k - $14.58k
...opportunity? We are seeking a highly skilled Senior Manager/Associate Director, Regulatory Operations to support and help drive regulatory success... ...will provide operational leadership supporting global regulatory submissions, regulatory information management,...OperationsSeniorShift work- ...Incredible opportunity to shape global regulatory strategy and deliver... ...integrate strategic thinking with operational execution across all stages... ...cross-functional teams and senior leadership to drive clarity... ..., process efficiency, and submission readiness. • Prepare and...OperationsSeniorWork at officeRemote workWork from homeWorldwide
- Vertex Pharmaceuticals is seeking an Associate Director, Global Submission Management in Boston to lead a portfolio of global regulatory submissions across development and lifecycle programs, including Pulmonary or Cell & Gene Therapy areas. You will partner with Global...
- ...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
- ...for as a firm. KPMG is currently seeking a Manager or Senior Manager to join our Global Mobility Services (GMS) practice. Responsibilities:... ...others, exhibit trustworthiness, and safeguard business operations and company reputation. Pursuant to the California Fair...OperationsSeniorFull timeWork experience placementLocal area
- Vertex Pharmaceuticals in Boston is seeking a Regulatory Publishing Senior Manager to lead the creation, assembly and publishing of electronic submissions for global health authorities, delivering accurate content on schedule. You will manage a portfolio of submissions,...Senior
$220k - $340k
...heard. About The Role The Global Safety Officer (GSO) serves... ...development through regulatory submission and, as applicable, post-marketing... ...-scientist who can operate with the rigor of a large... ...Management Team. Title (Medical Director vs. Senior Medical Director) will be...OperationsSenior$195k - $330k
...Lead the development and execution of global regulatory CMC strategies for degrader programs across... ...approve CMC content for regulatory submissions, including INDs/CTAs, briefing... ...strategic regulatory CMC guidance to senior leadership regarding health authority...Senior
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