LOCATION: CORK, IRELAND (FUNDED RELOCATION PACKAGE AVAILABLE)
The purpose of the Central Regulatory Registration (CRR) Associate role is to manage a portfolio of molecules/products for global regulatory registrations in major markets across the products’ lifecycle from candidate selection through product withdrawal. This person will have the responsibility to create and maintain complex strategic and compliance submissions through collaboration, document management, and internal database maintenance. The Associate collaborates with Regulatory Associates, Regulatory Scientists, cross-functional contributing/authoring areas, and affiliates to align on submission specific strategies and to ensure adherence to eCTD regulations and guidelines. The Associate is expected to provide business process knowledge and leadership to customers to resolve publishing issues and drive on time submissions The Associate also works closely with Regulatory Associates and Regulatory Scientists to manage information from regulatory agency interactions to ensure appropriate tracking of project timelines, pending approvals, and commitments. The Associates work involves technical, cross-functional processes in an environment of critical time frames and potentially changing priorities, therefore, a strong emphasis is placed on teamwork, leadership, communication, and self-management.
Functional and Technical Expertise
- Serve as electronic secondary publishing process expert to create, update, maintain, and archive complex dossiers using appropriate lifecycle management.
- Act as primary publishing lead on large marketing applications and coordinate the combined efforts of additional publishers, Regulatory Associates, Nonclinical publishers, CMC publishers, and Labelling to deliver the submission.
- Accountable as process owner of a specific process. (e.g., ROCs/IC, RAPT eFiles, Publisher Qualification, CRF/CRT, OUS Submissions, etc.) to technically evaluate, drive improvements and contribute to RQS procedures.
- Apply high level of technical expertise and proficiency in electronic publishing tools and systems (e.g., eCTDXpress, ISI Toolbox, Adobe Acrobat, Leo, Global Content Gateway, and LillyNet [SharePoint]) to ensure compliance. Stay up to date on system and tool upgrades.
- Coordinate across geographies to create different dossiers for Europe, Swiss, Canada or other supported worldwide markets. Collaborate with affiliate publishers to align and deliver on local specifications for the submission.
- Coordinate with RACMC Regulatory Scientists to process, publish, and submit U.S. FDA required post-marketing supplements and amendments. Recognize erroneous metadata and/or documents and influence to correct.
- Leverages internal and external forums to continue to develop and share regulatory and drug development expertise around electronic submission structure and content.
- Educate and influence cross-functional DCoE, Sci Com, and Labeling consultants on submission requirements for CRFs, datasets, literature references, and labelling, to ensure alignment and reduce potential technical issues impacting submission timelines.
- Lead the coordination with other publishing centers and contributors (e.g., GMC, Data Services, Regulatory Scientists, NIS, RACMC, IT experts, affiliates) through the compiling process to validate pre-submission accuracy.
- Archive registrations, assuring all metadata fields are complete and accurate to facilitate timely retrieval from eFiles.
- Identify gaps and define needs to optimize publishing processes/tools that meet agency preferred specifications and CRR submission work.
- Identify molecule specific eCTDXpress publishing errors/issues and influence Regulatory Associates/authors/vendors/consultants to correct errors and coach to build capability for future submissions.
- Test new software updates and identify/report issues impacting publishing.
- Ensure compliance submissions are delivered on time.
- Initiates consultation with Regulatory Associates and Regulatory Scientists to share best practices and move towards more efficient/effective work processes.
- Perform quality review of peer’s submissions to ensure accuracy/compliance and coach to improve.
- Train new Submission Publishers.
- Conduct submission planning for assigned portfolio by identifying publishing milestone requirements for upcoming submissions and planning/managing workload to ensure on time submissions, proactively seeking resources when needed.
- Lead troubleshooting investigations for compile issues for assigned molecules.
- Coordinate and communicates with Regulatory Associates to prepare for unique requirements for the molecules and plan for upcoming submissions.
- Proactively review multiple document sites to assess timing of document readiness from upstream authors and work ahead to publish documents.
- Serve as a single point of contact for customers (e.g., Regulatory Associates, Regulatory Scientists, authors, cross functional stakeholders) for managing the submissions in eCTDXpress backbone.
- Partner with other geographies to identify, understand, and incorporate EU and OUS agency regulations and county specific requirements to effectively influence the electronic registration plan.
Minimum Qualification Requirements:
- Degree qualified in a related field
- Three years’ experience publishing submissions using eCTDXpress.
- Demonstrated project management and time management skills.
- Demonstrated ability to communicate and negotiate solutions to complex technical challenges with cross-functional colleagues and customers.
- High-end computer and word processing/editorial skills: templates, spreadsheets, graphics, databases.
- Proficiency in SharePoint technology.
- Proven ability to take initiative and identify issues and solutions.
- General knowledge of scientific literature and library retrieval.
- Ability to work well independently and as part of a team, and ability to assertively marshal the efforts of multiple contributors to projects.
- The individual must be able to maintain the security of confidential information.
Other Information/Additional Preferences:
- This position reports functionally to a CRR Manager.
- This position is office-based work.
- The shift for the position is Monday through Friday, 8 hours a day.
Permanent, Full Time
Additional Salary Info
- Industry Sector Health, Nursing