Oncology Regulatory Lead - Strategic IND/NDA Expert Remote
Jobleads-US
- Remote job
Astellas is seeking a senior Regulatory Affairs professional based in Northbrook, IL, with global experience and a track record in NDA/IND strategies. You will lead submissions, interact with the FDA and health authorities, and guide cross‑functional teams through complex regulatory pathways.
Responsibilities include developing regulatory strategies, preparing registration packages, and mentoring staff while ensuring timely, compliant submissions across global projects.
#J-18808-Ljbffr Jobleads-US$228.1k - $325.85k
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...a rapidly growing oncology portfolio with potentially... ...Director, Global Regulatory Lead - Oncology, where... ..., provide expert guidance, and lead... ...development stages. Provide strategic, operational and... ...submissions (NDA/BLA/MAA)For the... ...Takeda's Hybrid and Remote Work policy.#LI-Hybrid#LI...Remote workRegulatoryMinimum wageTemporary workLocal areaWorldwide$227.42k - $275.58k
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- Affirm is seeking an Analytics Lead, Strategic Insights for Compliance Shared Services to own regulatory analytics and automated monitoring for a multi-product consumer lending business. You translate regulatory obligations into automated data checks and translate data...Remote jobRegulatory
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$154.4k - $242.55k
...Brand Insights and Analytics Lead, US Oncology is an Associate Director-... ...and Analytics and serves as a strategic insights and analytics partner... ...simultaneouslyKnowledge of regulatory requirements and compliance... ...accordance with Takeda's Hybrid and Remote Work policy. #LI-...Remote workRegulatoryMinimum wageTemporary workLocal area$136.86k - $195.51k
...areas that include oncology, ophthalmology,... ...Purpose & Scope The Lead, Upstream Marketing... ...a subject-matter expert for upstream HCP marketing... ...insights into strategic recommendations... ...Access, Legal, Regulatory, and Compliance to... ...Northbrook, Illinois. Remote work from anywhere...Remote workRegulatoryWork at officeWork from homeWorldwide- ...seeking a seasoned Global Procurement Associate Director - Strategic Sourcing Lead to steer the Contract Manufacturing sourcing program,... ...external supply goals, and drive measurable value while ensuring regulatory compliance. You will guide a global team, shape sourcing...Remote jobRegulatoryContract work
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...areas that include oncology, ophthalmology,... ...leadership role in the Regulatory Affairs department... ...a CMC regulatory lead for highly complex... ...as CMC regulatory expert by global project... ...participating in strategic planning in therapeutic... ...Westborough, MA. Remote work from anywhere...Remote workRegulatoryWork at officeLocal areaWork from homeWorldwide- ...client-focused business development leader to grow and manage strategic relationships focused on contaminated sediment projects, including... ...strategies, develop proposals, and position Foth as a trusted partner for regulatory-aware solutions across #J-18808-Ljbffr FothRemote jobRegulatoryFlexible hours
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...areas that include oncology, ophthalmology,... ...Global Statistical Lead (GSTATL) for Solid... ...plays a key role in regulatory and payer strategy... ...Accountabilities: Strategic Statistical... ...statistical genetics experts in oncologyRWE analysts... ...Northbrook, IL. Remote work from anywhere...Remote workRegulatoryWork at officeWork from homeWorldwide- ...Reference26-01029Remote50% Remote Responsibilities: Lead and manage clinical... ...activities for oncology clinical trials,... ...standards. Provide strategic oversight and direction... ...study protocols and regulatory requirements. Oversee... ...meetings, providing expert guidance on data-related...Remote workRegulatoryWork at office
$110k - $207.5k
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...through in neurology and oncology, with a strong... ...Director, Americas Network Lead will be responsible for... ..., cloud connectivity, remote access solutions,... ...financial alignment to strategic priorities.Manage ongoing... ...requirements, GxP guidelines, regulatory expectations, and...Remote workRegulatoryFull timeContract workWork at office- ...Associate Director of CMC Regulatory Affairs to lead regulatory activities for IND/CTA development, with future MAA/NDA/BLA planning. This high-profile... ...professional with oncology experience. You will deliver... ...regulatory compliance and strategic filing solutions, driving...Regulatory
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