Clinical Regulatory Delivery Lead - eCTD Submissions
Jobtailor
Jobtailor in Indianapolis, IN, seeks a regulatory operations professional to lead the registration management process, ensuring compliance with electronic submission regulations and global ICH standards. Collaborate across geographies and guide development teams on regulatory requirements for submissions. The role requires expertise in CTD/eCTD structures, complex lifecycle submissions, and strong project management capabilities to drive end-to-end registration planning and execution. #J-18808-Ljbffr 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...Regulatory
$111.2k - $258.7k
...tomorrow.As a Lab Coagulation and Clinical Chemistry II Subchapter lead in the Medical Value Assays Chapter... ...of the Medical Value Assays Regulatory Affairs Leadership Team (MVA RALT)... .... You have experience with global submissions for US FDA (Class 1-3), EU Notified...RegulatoryFull timeLocal areaRelocation package$64.5k - $151.8k
...ready to bring your best to work that truly matters for patients, we invite you to join us. Position SummaryThe Technical Delivery Lead in Clinical Results will be responsible for hands-on technical delivery, portfolio execution and oversight of the technologies that ingests...SuggestedFlexible hours- ...Medicine Department of Neurology seeks a Clinical Research Coordinator to support protocol... ..., recruitment, data handling and regulatory compliance at the IU Health Neuroscience Center. Responsibilities include IRB submissions, budgets, contracts, staff training, inventory...Regulatory
$65.25k - $148.5k
...portfolio by enabling delivery of observed and analysis... ...Data Bases and submission deliverables.People -... ...management, data and regulatory expertise/knowledge, e... ...PreferencesExperience in clinical data management and/or... ...Women’s Initiative for Leading at Lilly (WILL).Actual...RegulatoryFull timeH1bLocal areaVisa sponsorshipWork visaFlexible hours- Lead the registration management process by providing expertise in electronic submission regulations and guidance Partner with other geographies... ...processes Partner with the Regulatory Coordinator/Scientist to... ...industry Experience with CTD/eCTD structure and format Experience...RegulatoryFull timeLocal area
- Lilly is seeking a Technical Delivery Lead in Clinical Results to oversee hands‑on technical delivery, portfolio execution, and data‑driven platforms across a regulated lab ecosystem. You will lead the Clinical Lab portfolio, define roadmaps, and partner with engineering...
- Lilly in Indianapolis, IN seeks a Technical Delivery Lead in Clinical Results to drive hands-on delivery, portfolio execution and oversight of data ingestion, transformation, and management in a regulated lab ecosystem. You will design, build, and evolve data platforms...
- create and maintain regulatory registrations from candidate... ...agency’s preferred eCTD specifications in a... ...areas manage multiple submission types across assigned... ...Share Point Calendar for delivery of planned documents in... ..., nonclinical, clinical) Strong knowledge of global...RegulatoryFull timeWorldwideDay shift
- Eli Lilly and Company invites applications for a Technical Delivery Lead in Clinical Results, overseeing hands‑on delivery and portfolio execution of data platforms in a regulated lab ecosystem. You will design, build, and maintain ingestion, transformation, and data management...
- ...in alignment with study objectives Partner with Clinical Build Programmer to ensure complete data build for... ...Project Plan, database, and observed datasets) Support submission, inspection and regulatory response activities Lead cross Business Unit/Therapeutic Area projects or...Regulatory
- Elanco is seeking a Project Lead Data Manager to serve as a technical authority... ...leader in achieving global clinical data management objectives. You will... ...Clinical Development, Biostatistics, and Regulatory Affairs to deliver submission-ready databases in compliance with...Regulatory
- ...Indianapolis, IN seeks a Sr. Advisor - Statistics to lead statistical design and analysis for clinical trials, collaborating with physicians and... ...quality collaboration, and communicating results for regulatory submissions and manuscripts with a senior, cross-functional team...Regulatory
$50k - $60k
...translational research in disease models, and clinical trials in rare and common genetic... ...electronic files and/or filing regulatory documents appropriately; prepares and submits... ...principal investigator (PI) in making submission determination of SAEs, and follows up to...RegulatoryFull timeWork experience placementRemote workFlexible hours- Provide clinical direction, oversight, and support to assigned... ...across the region. Lead clinical teams in the delivery of safe, ethical, evidence... ...on-site leadership during regulatory or accreditation surveys... ..., implement, and monitor submission processes for required clinical...RegulatoryLocal area
- Lilly in Indianapolis, IN seeks a skilled statistician to support clinical trial analysis and regulatory submissions. You will collaborate with study teams, apply SAS and other tools, and contribute to statistical methods for complex trials. This full-time role offers...RegulatoryFull time
- ...our clients and advancing clinical research projects. As a part... ...candidates with experience leading global studies in a variety... ...excellence through on time delivery within budget and to the highest... ...process through regulatory submissions. Additional years of experience...RegulatoryRemote work
- Elanco in Indianapolis, IN, is seeking a Clinical Development Scientist - Parasiticides to lead global clinical programs for farm and companion animal parasiticides from early development through regulatory submission. You will design study protocols, coordinate cross-...Regulatory
- Lilly in Indianapolis, IN seeks a senior statistician to lead statistical analysis for clinical trials. You will collaborate with study teams, select methods, and communicate results for regulatory submissions and publications. The role requires a Master’s in Statistics...RegulatoryFull time
- ...Vice President of Clinical Pharmacology About the Company Forward-thinking... ...strategic input for NDA/MAA submissions, and contributing to the interpretation... ...pharmacology sections for regulatory submissions, as well as leading and collaborating on cross-functional...Regulatory
- ...our clients and advancing clinical research projects. As a part... ...candidates with experience leading global studies in a variety... ...excellence through on time delivery within budget and to the highest... ...process through regulatory submissions. Additional years of experience...RegulatoryRemote workWork from home
- ...development process, regulatory/business... ...support the expedited delivery of safe and effective... ...from the start of clinical trials through withdrawal... ...in electronic submission regulations and... ...BLAs, NDSs, other eCTD MAAs, Renewals and... ...needed. For example, lead the planning and...RegulatoryLocal area
- ...MMS is a award-winning, data-focused clinical research organization (CRO). We pride... ...scientific approach to complex trial data and regulatory submission challenges. With a global footprint... ..., MMS not only maintains an industry-leading customer satisfaction rating but also...RegulatoryRemote work
- ...Therapeutics, Inc. is looking for a Sr Director, Clinical Delivery Capabilities in Indianapolis, Indiana. This role is responsible for leading the operational and strategic direction... ..., ensuring compliance with quality and regulatory frameworks while partnering with external...Regulatory
- MiraVista Diagnostics in Indianapolis, IN is seeking a Clinical Laboratory Scientist to perform clinical assays, verify results, and support test operations. This role emphasizes QA, regulatory compliance, and accurate data handling as part of the Clinical Services Team...RegulatoryDay shift
- ...Clinical Documentation Coordinator Clinical Documentation Coordinator opening at Anew Care. Position is onsite in Indianapolis, IN... ...This role is essential in ensuring timely document completion, regulatory compliance, and operational efficiency across our clinical...Regulatory
$100.5k - $186.7k
...we love. That’s what makes us Roche.The OpportunityAs a Clinical Development Lead (Medical & Scientific Writing), you will serve as a... ...documentation strategy and lifecycle management to support regulatory submissions and advance patient care across key disease areas...RegulatoryFull timeLocal areaRemote workRelocation package- Jobtailor seeks a Regional Clinical Director to lead clinical services across multiple residential facilities in Indiana. You will guide teams... ...focuses on quality improvement, documentation accuracy, and regulatory readiness, with travel to facilities required to maintain...Regulatory
$177k - $308k
...Statistician at the Director level. This role includes providing statistical leadership for clinical research projects, developing innovative study designs, and ensuring compliance with regulatory standards. The ideal candidate will have a Ph.D. in Statistics or Biostatistics...Regulatory- Bristol-Myers Squibb is looking for a Director, Clinical Supply Chain & Planning in Indianapolis. This role involves managing the domestic... ...order fulfillment of clinical trial products, ensuring regulatory compliance, and developing strong supplier relationships. The...Regulatory
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