Remote Regulatory Project Director for Global Submissions
Travere Therapeutics
- Remote job
Travere Therapeutics seeks an Associate Director, Regulatory Project Manager to lead global regulatory activities and ensure submissions align with development plans. Remote in San Diego is supported, with limited travel to support cross-functional teams. You will oversee integrated timelines, mentor staff, and drive process improvements while coordinating across Regulatory Affairs, Clinical Development, CMC, Quality and Commercial to ensure compliance and timely filings. #J-18808-Ljbffr Travere Therapeutics
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- ...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...Suggested
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...to shine? Join us as an Associate Director, Global Regulatory Project Management and Strategic Planning -... ...Regulatory Affairs organization, based remotely. Partners with the Global... ...goals. Leads cross‑functional project submission working groups (SWG) to deliver successful...Remote workMinimum wageFull timeLocal areaWorldwide$235k - $280k
...Job Title: Senior Director, Global Regulatory Affairs Reports to (Title): VP,... ...Hybrid for NJ/MA candidates & Remote for out-of-state Job... ...NDA, BLA, and MAA submissions, providing an exceptional... ...resourcing and balancing project support across portfolio products...Remote workFull timeMonday to Friday- ...About Freyr Freyr is a global Regulatory Affairs and Life Sciences consulting... ...Location: Princeton NJ, - Remote Job Description: Key... ...framework, scope, and project timelines, to relevant stakeholders... ...approval of regulatory CMC submissions. Develop and manage...Remote workPermanent employmentFull timeLocal areaFlexible hours
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...to patients worldwide.The Director Global Regulatory Affairs, Neuroscience is responsible... ...complex and/or multiple projects. Keeps abreast of new... ...for all US FDA submissions and approvals of project(s... ...following Takeda's Hybrid and Remote Work policy.#LI-Hybrid#LI-...Remote workMinimum wageLocal areaWorldwide- ...the better. Chiesi Global Rare... ...doCurrently seeking a Regulatory Affairs (RA) Manager... ...a broad range of submissions to Regulatory Authorities... ...multidisciplinary project teams on regulatory... ...functions and Senior Director or Reg CMC Lead,... ...arrangements, remote work options, and...Remote workHourly payWork at officeLocal areaRelocation packageFlexible hours
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San Diego, CAClinical - Regulatory /Full-Time /HybridThe Senior Director, Global Regulatory Affairs will... ...(CTR) and CTA submissions.Serve as the primary regulatory... ...and externally.Strong project management and organizational... ...in San Diego office. Remote permitted upon approval...Remote workFull timeSummer workWork at officeRelocationRelocation packageShift work$177k - $278.08k
...patients worldwide.Join Takeda as Director, Global Regulatory Labeling Strategy where you... ...Documents Authoring, Submission, and Labeling Negotiations... ...assigned products.Employs strong project management skills to... ...is currently classified as "remote" in accordance with Takeda'...Remote workMinimum wageLocal areaWorldwide- ...The Senior or Executive Director, Global Regulatory Strategy is a key leadership role responsible for... ...and decision frameworks This is a remote role operating from the US,... ...experience leading major regulatory submissions (IND/CTA, BLA/NDA and/or MAA), including...Remote workFull time
- ...Senior Director, Global Regulatory Strategy The Senior Director, Global Regulatory Strategy is a senior regulatory executive responsible for... ...Strategy and Portfolio Leadership Regulatory Submissions and Lifecycle Management Health Authority Interactions...Remote workTemporary workFlexible hours
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...Position: Director, Global Regulatory Affairs Department: Development - Regulatory... ...Location: U.S (Remote) with up to 20% domestic travel... ...and mentorship across project teams. Responsibilities... ...direction of major regulatory submissions, including INDs, CTAs,...Remote jobFor contractorsWork from homeOverseas- Ladders is seeking a Senior Director, Regulatory Affairs CMC to lead global regulatory CMC strategy for development... ...approvability, manage complex submissions, and help resolve technical issues... ...global environment, with US-based remote eligibility. #J-18808-Ljbffr LaddersRemote job
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...Cambridge, MAPOSITION: Senior Manager, Global Regulatory Affairs, Marketed ProductsPOSITION... ...and vendors to ensure global regulatory submissions are provided to local company affiliates... ...regulatory strategy. Up to 75% remote work is allowed. Up to 30% domestic travel...Remote workMinimum wageFull timeWork at officeLocal area- Padagis is seeking a Director or Associate Director of Regulatory Affairs to oversee regulatory strategies and submissions for US products, including ANDAs for generics. You will lead... ...from development through approval. Remote-friendly with preference for Minneapolis...Remote work
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Senior Manager, Global Regulatory Affairs Labeling This range is provided... ...****@*****.*** 100% remote in eastern or central time... ...to internal approval and/or submission of labeling to health authorities... ...is essential. Strong project management skills and attention...Remote workFull timeWork experience placementLocal area$139.1k - $251.45k
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...the optimal balance between remote and in-office work. Discover... ...&D: Our approach to R&D Global Regulatory Affairs Manager, Oncology... ...interactions, reviews, and submissions with regional/local regulatory... ...fluency tools to enhance project delivery, efficiency, and innovation...Remote workFull timeWork at officeLocal area$72k - $87k
...Position Overview The Global Customs Compliance Manager... ...while mitigating regulatory risk. Key Responsibilities... ..., purchase orders, projects, and supporting documentation... ...documentation of submissions and monitor claims... ...work independently in a remote environment and prioritize...Remote workContract workLocal area$135.3k - $202.9k
...globe.Scope: The Associate Director, Global Regulatory Affairs Lead is... ...execution for their assigned projects in their region / country.... ...team.Drive the regulatory submission in your respective region.... ...Monday and Friday offered as remote flexible.Pay Range for this...Remote workLocal areaMonday to FridayFlexible hours- Green Key Resources is seeking a highly technical Regulatory Affairs Manager / Senior Manager in... ...onsite Tue-Thu. You will author and coordinate CMC submissions, manage regulatory strategy, and collaborate with global teams and CMOs/CROs. The ideal candidate has a...
- Kite Pharma in Santa Monica, CA, seeks a Manager, Global Regulatory CMC to lead regulatory submissions and lifecycle management for its autologous CAR‑T portfolio across the US, EU and other regions. The role partners with Operations, Quality, Process Development and Regulatory...Relocation
$154.4k - $242.55k
...to teams for the delivery of global regulatory strategies to support... ...development team on the assigned project(s) of responsibility.Partner... ...execution of required maintenance submissions/notifications to ensure... ...tailored communicationLocation: Remote within the USTakeda...Remote workMinimum wageLocal area- ...Company: Freyr Inc; The Largest Global Regulatory Solutions & Services... ...Strategy, Intelligence, Dossiers, Submissions etc. to Post- Approval /... ...Job title: Regulatory Project manager Job Type: Permanent... ...Work Location: Princeton NJ (Remote) Description: Experience...Remote workPermanent employmentFull timeWork at office
- ...We are growing our Regulatory Project Management team, and we'd love to connect... ...of high-quality regulatory submissions Contribute to long-term... ...of successfully leading global regulatory projects and achieving... ...execution. #LI-LB1 #LI-REMOTE EEO Disclaimer Parexel...Remote workWork from home
- ...Artivion, visit our website, .Position Overview:The Sr. Project Manager, Global Regulatory Intelligence will monitor, gather, and analyze global... ...skills applied to all assignments.May support regulatory submissions. Track and report the status of regulatory actions and...Full timeWork at officeWorldwideFlexible hours
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