Global eCTD Submissions Specialist
Jobtailor
Jobtailor seeks an experienced Regulatory Submissions Specialist to lead eCTD submissions across multiple markets from registration through product lifecycle. The role requires 5+ years in pharmaceutical regulatory operations, knowledge of CTD/eCTD, and proficiency with eCTD publishing tools such as eCTDXpress or Veeva. You will collaborate with Regulatory Associates and vendors to ensure timely, compliant submissions. #J-18808-Ljbffr Jobtailor
- Lilly is seeking a Global Regulatory Lead (GRL) to own global regulatory strategies from entry through end of life. You will lead a... ...US FDA relationship, shaping development plans and regulatory submissions. This role is based in Indianapolis, IN with 10-15% travel and...SuggestedRelocation package
- Genesys is seeking a Program Specialist, Solution Consulting Operations to coordinate operational programs, maintain KPI reporting, and drive alignment across regional and global teams. You will own planning, tracking, and documentation to improve delivery and decision-...Suggested
$84.3k - $155.4k
...role ends on 09/01/2026.Work you'll doAs a Specialist, Government Client Contracts Management... ...and interprets federal customer post-submission clarifications and/or deficiencies; coordinates... ..., please direct your inquiries to the Global Call Center (GCC) at USTalentCICInbox@...SuggestedContract workFor contractors$286.5k - $420.2k
...matters for patients, we invite you to join us. The Associate VP, Global Medical Affairs - Immunology (Rheumatology, Respiratory &... ....Role model and functional member of the appropriate research, submission, registration and commercialization support teams.Visibly active...SuggestedLocal areaFlexible hoursShift work$169.5k - $248.6k
...for patients, we invite you to join us. About the RoleAs the Global Regulatory Lead (GRL), you will be the accountable decision maker... ..., and issues managementUS FDA OversightOversee all US FDA submissions and agency interactions, including INDs, NDAs, and BLAsDrive high...SuggestedLocal areaFlexible hours- Roche in Indianapolis is seeking a P&C Enabling Support Specialist who thrives in a global, collaborative environment. You will connect dots across functions, manage events, and drive process improvements in a fast-paced network. The role requires a university degree or...Worldwide3 days per week
$118k - $197k
At Elanco (NYSE: ELAN) - it all starts with animals!As a global leader in animal health, we are dedicated to innovation and delivering... ...& Quality, Finance, and Technical Services), and ensure our submissions in the United States (US), European Union (EU), and other...Full timeSummer workLocal areaRemote workRelocationFlexible hours- Lilly in Indianapolis, Indiana, is seeking a Global Regulatory Lead to guide global regulatory strategies and oversee FDA submissions from early development through lifecycle. You will lead a cross-functional team and manage external stakeholder relationships to ensure...
- Lilly in Indianapolis, IN is seeking a Regulatory CMC leader to drive global submissions and lifecycle strategies for small molecule programs. You will provide strategic and operational guidance across clinical trials, marketing applications, and post-approval changes...
- Elanco Tiergesundheit AG is seeking a Sr Scientist - Global Regulatory Project Lead in Indianapolis, IN. This role involves guiding regulatory strategy and leading submissions for farm and companion animal products. The ideal candidate will have over 10 years of experience...Remote work
- Elanco is seeking a Senior Scientist, Global Regulatory Lead (Project Management) to guide regulatory strategy for novel farm and companion... ...with R&D, QA, safety, and manufacturing to ensure aligned submissions in the US, EU, and other key markets, while navigating risk...
- Lilly, headquartered in Indianapolis, Indiana, seeks a Global Regulatory Lead to drive global regulatory strategy from entry to end... ...including the US FDA interaction plan. You will oversee US FDA submissions (INDs, NDAs, BLAs), shape development plans, and align...
- Elanco is seeking a Feed Additive Regulatory Specialist in Indianapolis, IN. Hybrid work arrangements;... ...registration activities with FDA/USDA and ensuring all submissions meet regulatory standards. You will collaborate with global teams, support post-approval mandates, and...
- ...international bodies, and drive regulatory strategies across global projects. Based in a global role with travel, you will influence... ...teams, promote agile leadership, and ensure compliant, high-quality submissions across platforms. #J-18808-Ljbffr Roche Holding AG
- At Elanco (NYSE: ELAN) - it all starts with animals!As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship...Full time
$21.14 per hour
...entry and processing of various import related documentation for submission to US Customs and may handle all PGA's (participating... ...customers of all sizes solve the intricacies of shipping goods globally by providing comprehensive international ocean and air freight...Hourly payContract workWork experience placementRemote workMonday to Friday$84.3k - $155.4k
...Recruiting for this role ends on 09/01/2026. Work you'll do As a Specialist Lead, Procurement and Category Management on the GPS Contracts... ...in the recruiting process, please direct your inquiries to the Global Call Center (GCC) at ****@*****.***....Contract workWork experience placement- ...important challenges, and contribute to global progress. We know that teachers need support... ...and collaborate. The Bids & Proposal Specialist is responsible for managing and... ...bid qualification, proposal development, submission management, contract implementation, and...Contract work
$73.4k - $129.2k
...performance and priorities. As a Program Specialist, Solution Consulting Operations, you... ...consistent execution across regional and global teams. You will own the coordination and... ...such as application follow-ups or resume submissions-may not receive a response. Genesys is...Work experience placementWork from homeWorldwideFlexible hours- Lilly in Indianapolis is seeking a Global Regulatory Lead to steer global regulatory strategies from portfolio entry through end of... ...plans and addressing regulatory hurdles. You will oversee US FDA submissions and interactions, ensure alignment of affiliate plans with...
- Corteva Agriscience is seeking a Global Biology Leader (GBL) for Insecticides & Nematicide segment to join the Integrated Biology team within the Crop Health R&D function. As a key scientific and strategic leader, this role is accountable for creating the global biology...Local area1 day per week
- The Global Herbicide Resistance Leader is the subject matter expert for herbicide resistance, providing strategic and scientific leadership to support Corteva’s crop protection portfolio and pipeline innovations. This role leads global resistance management programs, drives...Local area1 day per week
$126k - $204.6k
...DevelopmentPosted Date: 2026-06-15At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing...Full timeFor contractorsFlexible hours- Job Summary: We are looking for a talented Talent Acquisition Global Process Excellence Coordinator to join our Cummins Inc. team in Indianapolis, IN . In this role, you will make an impact in the following ways: Drive process adherence by conducting reviews, identifying...Work experience placementWork at officeRelocation package
$115.5k - $184.8k
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life‑changing medicines to those who need them,...Full timeH1bVisa sponsorshipWork visaFlexible hours- Job Summary: We are looking for a talented Talent Acquisition Global Process Excellence Coordinator to join our Cummins Inc. team in Indianapolis, IN . In this role, you will make an impact in the following ways: Drive process adherence by conducting reviews, identifying...
- Senior Data Analyst, Global Incentive Compensation Analytics Position description: The Global Incentive Compensation (GIC) team at Salesforce is a global leader for sales compensation in the technology industry. We manage the sales compensation for all Salesforce, end-...
- ...strategic planning, execution and continual improvement of SAP solutions for the Allison Transmission business unit. The role will lead a global team of functional and technical SAP professionals in the delivery and support of a portfolio of SAP solutions to meet business...Full timeImmediate startWorldwide
$114.4k - $185.9k
Job DescriptionJob Title: Principal Controls Specialist - Modeling and SimulationWorking Pattern: Full-timeWorking location: Indianapolis... ...and Wyoming.Relocation assistance is available for this position.Global Grade Level CClosing date: 8/31/2026If you have questions...Full timeLive inWork at officeRemote workRelocation packageFlexible hours3 days per week- Job DescriptionJob Title: Controls Systems Specialist - Naval MarineWorking Pattern: FulltimeWorking Location: Indianapolis, IN/HybridRelocation... ...to appropriate standards and quality while engaging with a global engineering community to identify areas for collaboration and...Full timeFlexible hours
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