North America Regulatory Strategy Lead
Johnson & Johnson Innovative Medicine
Johnson & Johnson Innovative Medicine is recruiting for a Senior Manager, North America Regulatory Liaison. This hybrid role located in Spring House, PA; Titusville, NJ; or Raritan, NJ involves shaping NA regulatory strategy and leading end-to-end submissions for Immunology programs. You will partner with global and cross-functional teams to influence decisions, manage Health Authority interactions (e.g., FDA), and drive lifecycle management with a strategic, risk-balanced mindset. #J-18808-Ljbffr Johnson & Johnson Innovative Medicine
$137k - $235.75k
...their merit.Job Function: Regulatory Affairs GroupJob Sub... ..., United States of America, Spring House, Pennsylvania... ...for a Senior Manager, North America Regulatory... ...will be responsible for leading the end-to-end... ...regulatory submission strategy, identifying submission...RegulatoryFull timeTemporary workLocal areaImmediate start$137k - $235.75k
...their merit. Job Function Regulatory Affairs Group Job Sub... ..., United States of America, Spring House, Pennsylvania... ...for a Senior Manager, North America Regulatory... ...America regulatory strategy and execution for assigned... ...be responsible for leading the end-to-end planning...RegulatoryLocal areaImmediate start- ...Assurance and Compliance | North America Claims, Claims Shared Services... ...Services, this role will lead, oversee, enhance and optimize... ...with claim best practices, regulatory expectations, and technical... ...litigation management, settlement strategy, documentation quality,...RegulatoryFull timeWork at office
- ...operations.Senior Underwriter - North America Casualty ReinsuranceJob... ...relationship management, underwriting strategy execution and portfolio... ...long-term franchise value.• Lead complex underwriting... ...trends and risks.• Track legal, regulatory, economic and market developments...RegulatoryFull timeContract workWork at officeWeekend workAfternoon shift3 days per week
- ...dedicated to helping people lead longer and healthier lives.... ...Property Counsel for Dr. Reddy’s North America business. As an Attorney in... ...to design and implement IP strategies to advance Dr. Reddy’s... ..., Business Development, and Regulatory Affairs is required. Responsibilities...RegulatoryPermanent employmentWork experience placementWork at officeVisa sponsorship
- ...Group Lead Intellectual Property Counsel Full-time Job Family... ...Property Counsel for Dr.Reddy's North America business. This role will... ...direct, and execute robust IP strategies that protect and advance Dr.... ...with Portfolio, R&D, Regulatory Affairs, Business Development...RegulatoryPermanent employmentFull timeWork at officeVisa sponsorship
$193.28k - $289.92k
...Oversight and Relationship Lead is responsible for advancing... ...leaders on vendor oversight strategy and execution. Establish training... ..., Clinical Strategy, Regulatory Affairs, Quality, Finance, and... ...international presence across North America, Europe and Asia Pacific....RegulatoryFull timeFixed term contract$143.84k - $215.76k
...The Senior Manager, Omnichannel Strategy will serve as the digital strategy lead for Genmab’s 1st US based launch... ...stakeholders (Ops, Privacy, Data Science, Regulatory, IT) are accounted early and... ...international presence across North America, Europe and Asia Pacific. For...RegulatoryFull timeFixed term contractWork at office- ...dedicated to helping people lead longer and healthier lives.... ...Management who will enable the North America business in portfolio... ..., draw insights, help craft strategies to address portfolio gaps, and... ...Monitor intellectual property, regulatory, and competitor dynamics that...RegulatoryPermanent employmentFull timeWork experience placement
$182.32k - $273.48k
...People Operations Delivery, Americas is responsible for leading People Operations delivery... ...to translate Americas HR strategy into effective regional... ...standardization with local legal and regulatory requirements.Serve as the... ...presence across North America, Europe and Asia Pacific...RegulatoryFull timeFixed term contractWork at officeLocal area$117k - $201.25k
...recognize their merit.Job Function: Regulatory Affairs GroupJob Sub Function... ..., United States of America, Raritan, New Jersey, United... ...responsible for the following:Lead the development, revision, review... ...in the global labeling strategy, including demonstrating an understanding...RegulatoryFull timeLocal areaImmediate startWorldwide$164k - $282.9k
..., New Jersey, United States of America, Titusville, New Jersey, United... ..., and execute an AI vision and strategy that aligns with overall enterprise objectives.Lead the design, engineering, and operationalization... ..., ensuring compliance with regulatory and ethical standards (e.g., EU...RegulatoryFull timeImmediate start$137k - $235.75k
...Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States... ...data management and/or acquisition strategies, practices, methods, processes, and... ...with department SOPs, policies, and regulatory guidance documents.Lead or contribute to the development and...RegulatoryFull timeLocal areaImmediate start- Johnson & Johnson Innovative Medicine seeks a Principal Scientist (Manager) in Global Regulatory Affairs CMC to lead global regulatory strategies for large molecules, including vaccines and cell therapies. You will guide cross-functional teams, develop global dossiers,...Regulatory
$122k - $212.75k
...New Jersey, United States of America Role Summary This role combines... .... You will directly own and lead the product team for a set of... ...data products end‑to‑end (strategy, delivery, lifecycle and value... ...standards, security, privacy, and regulatory (including GxP if applicable)...RegulatoryRemote work- ...SUMMARY The Executive Director, Medical Strategy is a senior medical leadership role... ...Executive Management, Clinical Development, Regulatory Affairs, Commercial, Market Access,... ...products. The Executive Director will lead the design and implementation of comprehensive...RegulatoryFor contractors
- ...building materials. Heidelberg Materials North America operates over 450 locations across the U... ...and results-driven Hot Mix Asphalt Lead Person to support daily plant operations... ...with company policies, procedures, and regulatory requirements.What Are We Looking ForDemonstrated...RegulatoryHourly payTemporary workFlexible hours
$122k - $212.75k
...recognize their merit. Job Function Strategy & Corporate Development Job... ..., United States of America, Irvine, California, United States... ...patients from avoidable harms, 3) regulatory approvals and label... ...Finance teams and operations leads Internal Partnership Strengthening...RegulatoryFor contractorsWork at officeImmediate start- ...World Data Science group seeks an Associate Director to lead Operations, Planning and Strategy. This hybrid role requires 3 days in-office and can be... ...complex data partnerships, and ensure alignment with Credo and regulatory requirements. #J-18808-Ljbffr Johnson & JohnsonRegulatoryWork at office
- ...Sandoz Inc in Princeton, NJ, is looking for an Associate Director of Regulatory Affairs – Biosimilars to lead U.S. regulatory strategy for biosimilar development. This pivotal role involves overseeing regulatory submission processes and ensuring compliance with FDA regulations...Regulatory
- ...Johnson is seeking a Product Safety Head - Solid Tumors to lead safety strategy and risk management for marketed and developmental products... ...align processes, and ensure proactive safety assessments and regulatory communications. The role requires MD with 10+ years in...Regulatory
- Heidelberg Materials North America is seeking a safety-focused leader to supervise daily asphalt plant operations and coordinate production... ...meet schedules, troubleshoot issues, and uphold safety and regulatory standards in a fast-paced environment. A strong emphasis on...Regulatory
$122k - $212.75k
...Puerto Rico, United States of America, Titusville, New Jersey, United... ...translates global planning strategy into regional execution, brings... ...partners to deploy global standards, lead region-specific initiatives,... ..., and capability needs across North America and LATAM while...Full timeLocal areaImmediate startRemote workFlexible hours3 days per week- ...Sandoz International GmbH is seeking an Associate Director for Regulatory Affairs - Biosimilars in Princeton, NJ. This pivotal role involves leading regulatory strategies, managing submissions, and serving as a liaison throughout the product lifecycle. Applicants should...RegulatoryFlexible hours
$99.3k - $198.7k
...technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics,... ...lab results for millions of people. The Regulatory Labeling Lead will serve as the subject matter expert for regulatory labeling strategy across the i-STAT global IVD product...RegulatoryWorldwideShift work$209.6k - $313.38k
...Medical Director, Global Medical Strategy is a key leader within... ...affairs and serves as the medical lead for high priority programs.... ...publications, marketing, sales, regulatory, and all other cross... ...local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical...RegulatoryTemporary workLocal areaFlexible hours$243k - $297k
...Medical Director - Global Medical Affairs Lead (GMAL), Dermatology Position SummarySun... ...The incumbent will lead global medical strategy, evidence generation, scientific engagement... ...with Clinical Development, Commercial, Regulatory, HEOR, Safety, Medical Information, and...RegulatoryContract workFlexible hours$134.5k - $265.1k
Position Summary Manager - Commodity Solutions Lead - Enterprise Operations & RiskOur Deloitte Regulatory, Risk & Forensic team helps client leaders... ...client needs which span the organization and impact strategy, operations, performance and reputation.QualificationsRequired...RegulatoryLocal area$97.5k - $126.5k
...cornerstone of our culture. Ramboll in the Americas has thousands of experts working across... ..., NJ office. Ramboll is hiring for a Lead Consultant to join the Mergers & Acquisitions... ...support to clients across a variety of regulatory program areas including hazardous waste,...RegulatoryFull timeWork at officeLocal areaFlexible hours$122k - $212.75k
...strategic and experienced Value Stream Leads to drive the implementation of the SAP S... ...process expertise, a strong understanding of regulatory and compliance requirements in the life... ..., data migration validation, testing strategy (including GxP and CSV compliance), and...RegulatoryFull timeFor contractorsWork experience placementLocal areaImmediate start
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