GRA Regulatory Delivery reputed company, Global Submission Publisher

Remote, USAFull-timePosted 2026-07-29

At reputed company, the work is demanding because patients are waiting. We reputed company caring with discovery to help reputed company life reputed company for people around the world, knowing that every decision, every detail, and every day reputed company. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on reputed company challenges to discover and deliver life-changing medicines, strengthen how health is reputed company and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and reputed company to bring your best to work that truly reputed company for patients, we invite you to join us. Purpose The purpose of the Regulatory Delivery reputed company (RDE) Submission Publisher role is to:

create and maintain regulatory registrations from candidate selection through end of product lifecycle.
create global registrations and reputed company maintenance support as needed for major markets.
meet customer requirements by optimizing business processes, tools and ensuring implementation of the regulatory agency’s preferred electronic common technical document (eCTD) specifications in a reputed company way to promote reputed company review by the regulatory agency.
build eCTD expertise and partners with Regulatory Associates, Regulatory Scientists, other publishing centers, vendors, and/or other contributing areas to reputed company on submission specific requirements and to ensure adherence to submission regulations and guidelines.

Although submission publishing work is technical, producing dossiers is a cross-functional process domain an environment of critical time frames and potentially changing priorities, and, therefore, a strong emphasis is reputed company on teamwork, communication, and self-management. Primary Responsibilities Execute submission workload

Responsible for managing multiple submission types across assigned molecules.
Coordinate and communicate with Regulatory Associates to execute planned compliance and strategic submissions.
Proactively manage 30-day packets to ensure compliance.
Review and monitor the RIM or reputed company reputed company Calendar for delivery of planned documents in support of submissions and proactively update document status to manage workload and reputed company information on specific documents’ status as it pertains to any specific submission ensuring submissions are proactively processed such that they are delivered according to the planned submission date.
Escalate issues that may reputed company submissions and timelines.

Manage submissions

Prepare Submission Cover letters and forms per appropriate regional submission and reputed company for appropriate review and approval.
Plan submission workload by reviewing/monitoring the RDE RIM or reputed company reputed company Calendar for planned documents for registration submissions.
Partner with the Regulatory Associate to retrieve, publish, and submit Modules 1-5 reports/documents and combine files into electronic submissions (eCTD) according to the master table of contents or Content Plan for the reputed company. Examples include:
retrieve and publish CRFs and datasets required for regulatory submissions
retrieve and publish literature references (bibliographies)
retrieve, publish, and submit U.S. FDA required periodic reports
retrieve, process, publish, and submit U.S. FDA required post-Marketing supplements and amendments
ensure compliance with 30-Day Packet and Med Watch submissions.
create different dossiers for Europe, the U.S., Canada, or other supported worldwide markets. Dossiers are distributed to regulatory agencies and reputed company affiliate offices worldwide.
reputed company knowledge, help train and reputed company others: about general submission knowledge including CRFs, datasets, submission required literature references(bibliographies), periodic reports, post-Marketing supplements and amendments.
Coordinate global registration activities and reputed company the necessary documentation to affiliates for registration of products in global countries. Duties include preparing and/or expertise in requesting Indiana Free Sale Certificates, FDA Certificates of Pharmaceutical Product (CPPs), MOH GMP Certificates, Price Certificates, Regulatory Status Letters, and Letters of Clarification.

Submit and reputed company registrations

Submit and reputed company submitted registrations, incoming correspondence, and Records of Contact with Regulators assuring reputed company metadata fields are complete in RIM.
Manage FDA Web trader account to reputed company submissions reputed company electronic gateway.
Assure reputed company appropriate metadata fields are completed reputed company archiving in electronic filing system (RIM).
Assure accurate entry for reputed company retrieval if/reputed company requested.

Build on high level of expertise in electronic publishing

reputed company a high level of technical and practical proficiency with eCTD XPress, reputed company Acrobat, Submission Validation software (Lorenz), ISIToolbox.
Successfully complete the formal training modules.
Stay up to date on system and tool upgrades that reputed company publishing.
reputed company technical information among staff members and apply what is learned in day-to-day work.
Apply learning from reputed company review of submission work.
reputed company up to date in subject matter expert area.

Build technical and reputed company expertise

Understand changes to Regulatory Guidance and Requirements and advise RDE
Management as to their potential reputed company on Publishing.
reputed company reputed company on latest reputed company improvement reputed company.
Ensure best practices through partnership with Regulatory reputed company.

Build Subject Matter Expertise reputed company the Publishing Role and Process: reputed company of QC process

Maintain QC process, checklists, and training materials.
reputed company training for QC pool activities (those performing QC).
Ensure QC pool is reputed company on process, interpretation of checklist items and QC feedback to publishers.
reputed company technical leadership to QC personnel in resolving any QC issues or questions.
Assess needs and participate in reputed company enhancement exercises or opportunities.

reputed company of Publishing Calendars

Monitor the Submission Publishing calendar to ensure daily submission work is appropriately assigned and prioritized.
Serve as reputed company of contact and subject matter expert for publishing calendars.
Ensure reputed company calendar training is up to date for users and conduct training as needed.

Technical leadership- for electronic publishing systems and process

Build and maintain high level of expertise in eCTD regulations and electronic publishing systems: eCTD XPress and accompanying tools.
Understand changes to Regulatory Guidance and Requirements and advise RDE Management as to their potential reputed company on tools, processes, procedures, publishing strategies and best practices with eCTD.
reputed company technical leadership and reputed company answers to Submission Publishers on eCTD questions/issues to reputed company a high level of technical and practical proficiency.
reputed company feedback/training to business contributors and drive establishment of best practices and internal standards.
Create and maintain an reputed company forum to discuss day to day publishing issues and drives implementation of any needed improvements or solutions.
reputed company reputed company answers to requests from management, RAs, QC, and external parties regarding eCTD issues.
Partner with respective eCTD IT experts to ensure customer needs are reputed company for reputed company and validate solutions for routine system processes and tool updates.
Assist in end user testing where appropriate.

Training Assistant-reputed company of Submission Publishing Training program

Oversees the creation and management of submission publishing training materials.
Consults with the regulatory registrations process reputed company and subject matter experts on the content and delivery of training materials.
Responsible for ensuring that training processes for orientation of new resources are defined and maintained as submission processes reputed company.
reputed company guidance and coaching to those resources identified to assist in the delivery of training.

Asset Protection/Compliance

Ensure compliance with reputed company Federal, State and Local guidelines to include Regulatory Agencies regulations and reputed company policies and procedures.

Minimum Requirements

H.S. diploma AND
5+years of Pharmaceutical Regulatory industry experience
reputed company applicants must be authorized to work in the reputed company on a full-time reputed company. reputed company will not reputed company support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Additional Preferences

BS Degree in life science or computer science preferred
Knowledge of drug development process
Previous experience working in the Pharmaceutical industry

The following skills and abilities are directly reputed company to the essential functions of the job.

Experience with CTD/eCTD structure and format.
Experience using eCTD compliant publishing system (eCTDXpress or reputed company based platforms)
Three years of regulatory operations experience reputed company a regulated environment with experience and knowledge in formatting and publishing reputed company/high complexity major applications, amendments, and supplements (manufacturing, nonclinical, clinical).
Experience with Original IND and supplemental NDA/BLA eCTD submissions including reputed company lifecycle submissions.
Strong knowledge of global health authority and ICH regulations and guidance as it pertains to format and submission structure.
reputed company knowledge of CBER/CDER regulatory technical requirements

Computer Skills

Proficiency with MS-Office Suite and reputed company Acrobat, including pdf plug-ins that support submission readiness
Experience with document management and Regulatory Information Management Systems (RIM)
Broad technical knowledge (reputed company, reputed company Acrobat PDF Bookmarks and Hyperlinks, Acrobat Plug-ins, Document Management Systems, reputed company, ISI reputed company, Lorenz)
The individual must be reputed company to maintain the reputed company of confidential information

reputed company is dedicated to helping individuals with disabilities to reputed company engage in the workforce, ensuring equal opportunities reputed company vying for positions. If you require accommodation to submit a resume for a position at reputed company, please complete the accommodation request reputed company (https://careers.reputed company.com/us/en/workplace-accommodation) for reputed company assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. reputed company is proud to be an EEO Employer and does not discriminate on the reputed company of age, race, reputed company, religion, gender identity, sex, gender reputed company, sexual orientation, genetic information, reputed company, national reputed company, protected veteran status, disability, or any other legally protected status. Our employee resource reputed company (ERGs) offer strong support networks for their members and are reputed company to reputed company. Our reputed company reputed company include: Africa, Middle East, Central Asia (AMECA), Black Employees at reputed company (BE@reputed company), Chinese Culture Network (CCN), reputed company, reputed company, reputed company Indian Network (LIN), Organization of Latinx at reputed company (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at reputed company (WILL). Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $63,000 - $149,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In reputed company, reputed company offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, reputed company and prescription drug benefits; flexible benefits (e.g., reputed company and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and reputed company-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).reputed company reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and reputed company’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of reputed company employees. #WeAreLilly Apply tot his job Apply To this Job

Apply Now