Regulatory AI Tech Director Submission Excellence
6084-Janssen Research & Development, LLC Legal Entity
6084-Janssen Research & Development, LLC Legal Entity is seeking a Director, Technology Product Group Leader for Submission Excellence. This role involves overseeing the development, engineering, and global operationalization of solutions to accelerate regulatory submissions. The ideal candidate will have extensive experience in technical product development and a deep understanding of AI technologies supporting regulatory processes. The position offers a competitive salary range and comprehensive benefits. #J-18808-Ljbffr
$102k - $175.95k
...architecture while driving engineering excellence, automation, and modern DevOps practice.... ...services, monitoring/observability, and AI‑enabled automation). Own platform financial... ...execution. Ensure audit readiness and regulatory compliance by owning validation strategy...RegulatoryTemporary workLocal areaImmediate start- ...integration architectures across PLM, QMS, ERP, Regulatory, and other core systems. Drive adoption... ...to mentor and coach team members. Excellent verbal and written communication skills,... ...implement automation solutions. Demonstrates AI Fluency —the ability to use and evaluate...RegulatoryTemporary workFor contractorsWork at officeImmediate start
$150k - $258.75k
Job Title Director, Technology Product Group Leader - Submission Excellence Location Raritan, New Jersey, United States; Spring House, Pennsylvania... ...Excellence program, accelerating regulatory submissions through technology, automation, and AI. Major Duties & Responsibilities...RegulatoryTemporary workLocal areaImmediate start$199k - $343k
...way. Learn more at The Director, GMAL Pre‑Approval Access –... ...scientific integrity, operational excellence, and compliance across... ...patient requests. · Review HCP submissions to determine patient... ...compliance with SOPs, GCP, regulatory requirements, and internal PAA...RegulatoryTemporary workLocal areaRemote work- ...A leading tech firm is seeking a Product Manager with extensive experience in regulatory submission processes and health authority queries. The role requires strong customer-facing skills and a deep understanding of pharma regulatory processes. Candidates with over 10...Regulatory
$130k - $150k
...To $150,000.00 Annually EH&S Director Who Are We At Natural... ...environmental, health, safety, and regulatory programs. This position... ...monitoring reports and ensure timely submission Maintain OSHA 300 logs and U... ...accessing active work sites Excellent written and oral...RegulatoryFull timeTemporary workWork at officeLocal area- ...Authority query process Must Have Experience: Product Manager for regulatory submission process Must have experience as a Product Manager with... ...(Candidates with experience would have first preference Excellent customer facing skills with 10+ years of experience as product...Regulatory
$137.6k - $180k
...Regulatory Affairs Advertising Promotion Specialist This position... ...Reporting Structure Reports To: Director, Regulatory Affairs -... ...Office (Outlook, Teams, Word, Excel, PowerPoint) Familiarity with eCTD requirements and e-submission formats/processes of promotional...RegulatoryTemporary workNight shiftWeekend work$140k - $180k
Job Title Associate Director Government Pricing Requisition JR000... ...Legal, Government Affairs, Regulatory, Commercial, Finance, Accounting... ..., review, audit, and submission of federal pricing values including... ...complex regulations. ● Excellent communication, cross-functional...RegulatoryFull timeContract work3 days per week- ...Legend Biotech is seeking an Associate Director, GxP Compliance and Auditing as part of... ...logistics, supplier quality management, regulatory intelligence monitoring and dissemination... ...Microsoft Office applications (Outlook, Excel, Word, PowerPoint). Highly organized,...RegulatoryPermanent employmentFull timeFor contractorsWork experience placementWork at officeLocal areaWorldwideFlexible hoursShift work
$170k - $205k
Associate Director, Statistical Programming Job Category : Statistical... ...data management center of excellence. Building on this foundation... ...to clients, or submitted to regulatory agencies. These QC... ...supporting electronic regulatory submissions of clinical trial data for individual...RegulatoryFull timeContract workTemporary workWork at officeRemote workWork from homeWorldwide$126k - $242k
...seasoned, innovative, and hands-on AI Security leader to join Verizon... ...with enterprise risk, regulatory and cybersecurity requirements. The Associate Director will lead the identification, assessment... ...and critical thinking skills, excellent written, oral communication and...RegulatoryFull timeTemporary workPart timeWork experience placementWork at officeWork from homeShift work3 days per week- ...Description DePuy Synthes is recruiting for a Director, 3rd Party RM Program (BPO) located in... ...all regions while accommodating local regulatory requirements. Develop and maintain a... ...making and problem‑solving capabilities. Excellent written and verbal communication skills,...RegulatoryLocal area
- ...program Overview The Director will work within the... ...incorporating potential costs and regulatory hurdles for management... ...requests, proposing session submissions for consideration, coordinating... ...organized self-started with excellent communication skills and ability...RegulatoryWork at officeFlexible hours
$164k - $282.9k
...step of the way. Learn more at The Director, Oncology Pre-Approval Access (PAA)... ...R&D, Oncology Global Medical Affairs, Regulatory Affairs, Clinical Supply Chain, Pharmacovigilance... ...projects and drive operational excellence. • Excellent communication, organizational...RegulatoryTemporary workLocal area$214k - $292k
...expectations, and local market practices Drive operational excellence by optimizing benefits processes and leveraging technology and... ...regions (U.S., EMEA, Japan), with the ability to navigate diverse regulatory and cultural environments Demonstrated success driving...RegulatoryLocal areaRemote workFlexible hours$168.99k - $253.48k
...Director Alliance Management, North America The success of a company depends on the... ...will combine deep industry knowledge with excellent business acumen and exceptional... ..., including technological advancements, regulatory changes, and customer needs. •...RegulatoryContract workTemporary workFor contractorsWork experience placementWork at office$164k - $282.9k
...the way. Learn more at Position Title Director, Partnership Management Location The position... ..., and ensuring adherence to all regulatory and company standards. It is also accountable... ...management is required. Must have excellent verbal and written communication skills....RegulatoryTemporary workLocal areaImmediate startFlexible hours$234.6k - $284.28k
...working-with-us. The Region Director (RD) is a remote leadership... ...Commercialization System Excels at implementing transformational... ...boundaries established by regulatory and legal compliance in accordance... ...that the role of FM in the submission process of investigators'...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inLocal areaRemote workWork from homeHome officeFlexible hoursShift work- ...Synthes is recruiting for a(n) Director, Data Management & Tech Operations located in... ..., as may be required, regulatory approvals and other customary... ..., driving operational excellence and consistent execution... ...quality and compliance in all submissions. ~ Lead the sourcing,...RegulatoryWork at officeLocal areaWorldwide
$137k - $235.75k
...companies, is recruiting for an Associate Director, Global Compound Market Access, to... ...supporting payer negotiations and/or access submissions strongly preferred. Strong experience... ..., Organizing, Pricing Strategies, Regulatory Compliance, Strategic Change, Tactical...RegulatoryFull timeLocal areaImmediate start$164k - $282.9k
Job Overview Director, Global Real-world Evidence (RWE) in the Global Commercial Strategy... ...IEGP process. Ensure full compliance with regulatory, legal, and commercial regulations in... ...in standard office applications (Word, Excel, PowerPoint) and familiarity with statistical...RegulatoryTemporary workWork at officeLocal area$178k - $307.05k
...West Chester, PA Job Description Senior Director, Global Education Capabilities will... ...education solutions that enable customer excellence across regions and franchises. Responsibilities... .... Ensure compliance with applicable regulatory, legal, and quality requirements for...RegulatoryLocal areaWorldwide$160k - $276k
...States of America Job Overview Director, Global Real‑World Evidence.... .... Ensure compliance with regulatory, legal, and commercial requirements... ...advancements such as AI, machine learning, and causal... ...Highly motivated individual with excellent time management, skilled at managing...RegulatoryTemporary workFor contractorsLocal areaImmediate startWorldwide$150.8k - $226.2k
...drive sustainable quality and compliance excellence. Provide quality and compliance... ..., Inspections, QIs including late ICSR submission of reports, and their CAPAs, etc.) from... ...PV Quality perspective. Ensure adequate regulatory inspection and audits preparation. Responsible...RegulatoryLocal areaWorldwide- ...Johnson & Johnson in New Brunswick, NJ is seeking a Sr. Manager, Regulatory Affairs to drive technology product strategy for regulatory-focused digital capabilities. This role involves managing the end-to-end product lifecycle, working closely with Regulatory Affairs,...Regulatory
$153.6k - $230.4k
...resolution, and proactively drive operational excellence and continuous improvement. Manage DSI'... ...Good Pharmacovigilance Practice and regulatory compliance in such arrangements.... ...activities including, Safety Information submission to Health Authorities and License Partners...RegulatoryContract workLocal area$130k - $150k
...Job Description Job Description Director, Environmental Health, Safety & Compliance (EHS) Position Overview Our client in the... ..., policies, procedures, and reporting processes Monitor regulatory changes and ensure organizational readiness and compliance...RegulatoryLocal area$165k - $230k
...Innovating every day.™ Position Overview The Director, Human Resources serves as the principal... ...an operationally rigorous leader who excels at translating executive decisions and... ...match a multi-state, hybrid workplace. Regulatory Compliance: Maintain strict oversight of...RegulatoryTemporary workWork at officeLocal areaFlexible hours3 days per week$155k - $202k
...role defines the global QMS strategy ensuring compliance with regulatory standards across digital health products. The ideal candidate has... ...in quality management within a regulated environment, excels in leading strategies, and possesses strong communication skills...Regulatory
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