Biologics CMC Analytics Lead for Regulatory Strategy
Otsuka America Pharmaceutical Inc.
Otsuka America Pharmaceutical Inc. seeks a Senior Manager in CMC Data Analytics to drive data integration and analysis for biologics development. This role requires expertise in CMC data analytics and involves collaboration across multiple departments to ensure regulatory readiness. Candidates should have a strong background supporting IND and BLA submissions with an M.S. degree in a relevant field. Comprehensive benefits include medical, dental, and a generous 401(k) match. #J-18808-Ljbffr Otsuka America Pharmaceutical Inc.
- ...Responsibilities Develop and implement CMC regulatory strategies for vaccines, ensuring... ...requests for information. Lead discussions in formal... ...communications CMC experience for biologics, including regulatory... ..., quality control, and analytical methods Experience translating...Regulatory
- Jobtailor is seeking a regulatory affairs professional to develop CMC strategies for vaccines and manage FDA submissions for... ...as a primary FDA contact and leading agency discussions. The role emphasizes... ...and post-approval changes in biologics. #J-18808-Ljbffr JobtailorRegulatory
$150.03k - $224.25k
The Senior Manager, CMC Data Analytics is responsible for executing... ...CMC data to support biologics development from IND-... ..., MSAT, Quality, and Regulatory Affairs to analyze,... ..., risk-based control strategies, and informed CMC... ...take an active role in leading change. Strategic...RegulatoryTemporary workLocal areaFlexible hours- ...leader to direct Medicaid risk adjustment informatics, analytics, and reporting. You will shape strategies across markets, drive data‑driven decisions, and... ...ensure accurate revenue capture while maintaining regulatory compliance. This role emphasizes strategic leadership...Regulatory
$100k - $231.54k
...Integrity Informatics is seeking a Lead Director - Revenue Integrity... ...dynamic Risk Adjustment analytics team. This senior‑level role... ...execute Medicaid risk adjustment strategy across markets and plans... ...enterprise goals, market needs, and regulatory timelines Drive integration...RegulatoryHourly payFull timeTemporary workLocal area- ...seeks a Senior Product Manager to own the strategy, roadmap, and lifecycle of MSSR... ...investments and pricing decisions. You will lead cross-functional teams across engineering... ...solutions while monitoring market trends and regulatory changes to shape positioning and product...Regulatory
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Position Overview The Database Team Lead oversees the design,... ...critical business applications and analytics. This role leads a team of... ...organizational policies and regulatory requirements. Key Responsibilities... ..., and disaster‑recovery strategies across on‑premises and cloud‑...RegulatoryContract workWork at office- ...is seeking a Property Tax Manager to lead tax strategies and compliance initiatives. This role... ...consulting experience. You will advise on tax regulatory changes, manage compliance frameworks,... ...to client management and strong analytical skills are essential for success. #J-1...Regulatory
- Lead the strategic digital and AI partnership with AstraZeneca,... ...embedded in clinical development strategy, portfolio decisions and key... ...data quality and strengthen regulatory readiness. Act as the... ...document authoring, predictive analytics for study design, decentralised...RegulatoryContract work
- Own the end‑to‑end global regulatory strategy for a cell and gene therapy product or franchise of... ...management, and commercialization outcomes. Lead strategy for major health authority... ...‑standing experience of overall drug/biologic development processes and strategies for...RegulatoryFlexible hours
$124k - $211k
Job Description The Lead Actuary - Pharmacy Pricing leads complex... ...Monitor health policy, regulatory, and market developments and... ...assess implications for pricing strategy Ensure compliance with applicable... ..., or similar tools Strong analytical and problem-solving skills...RegulatoryRemote jobWork experience placementLocal areaVisa sponsorshipWork visa- Responsibilities Own the end-to-end global regulatory strategy for a high-complexity cell and gene... ...program Serve as global regulatory lead for complex, multi-indication programs... ...Long standing experience of overall drug/biologic development processes and strategies for...RegulatoryFlexible hours
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- Parexel is seeking a Manager, Regulatory Affairs Advertising & Promotion to join our team in Annapolis, MD. This role involves strategic... ...position offers the opportunity to act as a trusted advisor and influence regulatory strategy significantly. #J-18808-Ljbffr ParexelRegulatoryRemote job
$68k - $112k
...required Familiarity with Databricks Experience in Marketing Analytics with at least 1-2 years of experience with Marketing Campaign... ...translate analysis insights into actionable recommendations and strategies for the clients Ability to build XG Boost or Machine Learning...Temporary workLocal area- ...long‑term profitability and sound decision‑making. Actuarial & Analytics Lead: reserve calculations and pricing for auto products;... ...on product structure and acceptability criteria; ensure full regulatory compliance. Set strategic direction for risk management; mentor...Regulatory
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- ...date! Position Summary The Manager, AI Strategy leads the organization’s artificial... ...while protecting resident privacy and regulatory integrity. Performance Expectations (First... ...Healthcare Administration, Business, Data/Analytics, or related field (or equivalent experience...RegulatoryFull timeLocal areaFlexible hours
- UKG (Ultimate Kronos Group) is looking for a Lead Economist to guide workforce and labor market analytics. In this role, you will influence internal strategy and external market positioning through advanced economic modeling and analysis. You will establish thought leadership...
- Jobtailor seeks a senior regulatory affairs leader to steer global regulatory strategy for cell and gene therapies in a fast-paced environment. The role focuses on oncology, immune-mediated, and rare disease programs, guiding milestones from expedited designations to post...Regulatory
$169.4k - $279.6k
...way for best-in-class solutions. As a Lead Architect, you will collaborate with... ...execution of complex, large scale technology strategies. Leadership & Influence: Advanced... ..., responsible AI practices, and regulatory frameworks (EU AI Act, GDPR) Experience...RegulatoryTemporary workWork experience placementLocal area- Zoom is seeking a seasoned tax expert to lead its U.S. state and local tax strategy, ensuring compliance and driving AI-powered automation. The role involves collaboration with various teams to manage complex tax obligations effectively. Ideal candidates will bring over...Local area
- Jobtailor in Maryland is seeking a senior regulatory leader to own the end-to-end global regulatory strategy for a high-complexity cell and gene therapy program. You will serve as global regulatory lead for multi-indication programs, directing agency interactions and expedited...Regulatory
- ...seeks a DEI Program Manager to advance its North America DEI strategy and drive inclusive outcomes. You will partner with Senior DEI... ...Marketing to ensure program alignment with enterprise goals and regulatory requirements. You will design learning programs, manage...Regulatory
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- Stantec Consulting International Ltd. is looking for a Regulatory Specialist based in Maryland to provide technical leadership on Environmental... .... Your role will involve executing environmental permitting strategies and preparing necessary applications while coordinating with...Regulatory
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