Associate / Senior AssociateGlobal Regulatory Affairs-Cork-Regulatory Delivery & Excellence-Global Publisher
- Cork
- Permanent
- Full-time
- execute and maintain global regulatory submissions from candidate selection through end of product lifecycle.
- provide maintenance support as needed for submissions.
- coordinate the creation and legalization of regulatory submission documents supporting registration activities across the international region
- 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 quality way to promote timely review by the regulatory agency.
- build eCTD and/or non-eCTD expertise and partner with Global Regulatory Associates, Regional Submission Associates, Affiliate Regulatory, other publishing centers, vendors, and/or other contributing areas to align on submission specific requirements and to ensure adherence to submission regulations and guidelines.
of critical time frames and potentially changing priorities, and, therefore, a strong emphasis is placed on teamwork,
communication, and self-management.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 Share Point Calendar for delivery of planned documents in support of submissions and proactively update document status to manage workload and provide 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 impact submissions and timelines.
- Coordinate/facilitate the creation of Authorization Letters, Power of Attorney letters, and other corporate administrative documentation to support registration activities, and develop/maintain related business process documentation
- Coordinates apostille/legalization process for letters and certificates, as necessary Further develop and maintain archiving filing system
- Collaborate with Regulatory scientists, regional and affiliate regulatory colleagues to streamline and improve the document legalization practices
- Maintain transparent tracker of legalization activities and provide timely answers, advice, and document delivery to affiliates to meet the regulatory submission requirements
- Communicate changes to tools, processes and procedures that directly affect the documentation activities
- Stay current with the changing regulatory environment, new legalization requirements, and government standard practices
- Ensure quality assurance and appropriate documentation of submission documents
- Manage escalations in cases where urgent legalization is needed
- Submit and archive submitted submissions, assuring all metadata fields are complete in RIM.
- Manage FDA Web trader account to enable submissions via electronic gateway.
- Assure all appropriate metadata fields are completed when archiving in electronic filing system (RIM).
- Assure accurate entry for future retrieval of submissions if/when requested.
- Achieve a high level of technical and practical proficiency with RIM, Adobe Acrobat, Submission Validation software (Lorenz), ISIToolbox.
- Successfully complete the formal training modules.
- Stay up to date on system and tool upgrades that impact publishing.
- Share technical information among staff members and apply what is learned in day-to-day work.
- Apply learning from quality review of submission work.
- Keep up to date in subject matter expert area.
- Understand changes to Regulatory Guidance and Requirements and advise RDE
- Management as to their potential impact on Publishing.
- Keep current on latest quality improvement methods.
- Ensure best practices through partnership with Regulatory Quality.
- Maintain QC process, checklists, and training materials.
- Provide training for QC pool activities (those performing QC).
- Ensure QC pool is aligned on process, interpretation of checklist items and QC feedback to publishers.
- Provide technical leadership to QC personnel in resolving any QC issues or questions.
- Assess needs and participate in skill enhancement exercises or opportunities.
- Monitor the RIM Submission Publishing calendar to ensure daily submission work is appropriately assigned and prioritized.
- Serve as point of contact and subject matter expert for publishing calendars.
- 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 impact on tools, processes, procedures, publishing strategies and best practices with eCTD.
- Provide technical leadership and timely answers to Submission Publishers on eCTD questions/issues to achieve a high level of technical and practical proficiency.
- Provide feedback/training to business contributors and drive establishment of best practices and internal standards.
- Create and maintain an open forum to discuss day to day publishing issues and drives implementation of any needed improvements or solutions.
- Provide timely answers to requests from management, RAs, QC, and external parties regarding eCTD issues.
- Partner with respective eCTD IT experts to ensure customer needs are understood for timely and validate solutions for routine system processes and tool updates.
- Assist in end user testing where appropriate.
- Oversees the creation and management of submission publishing training materials.
- Consults with the regulatory registrations process owner 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 evolve.
- Provide guidance and coaching to those resources identified to assist in the delivery of training.
- Ensure compliance with all Federal, State and Local guidelines to include Regulatory Agencies regulations and Lilly policies and procedures.
- A minimum of 3-5 years in the biotechnology or pharmaceutical industry.
- Experience with CTD/eCTD structure and format.
- Experience using eCTD compliant publishing system
- BS Degree in life science or computer science preferred or equivalent work experience.
- Three years of regulatory operations experience within a regulated environment with experience and knowledge in formatting and publishing medium/high complexity major applications, amendments, and supplements (manufacturing, nonclinical, clinical).
- Experience with Original IND and supplemental MAA eCTD submissions including complex lifecycle submissions.
- Experience with non-eCTD submissions including complex lifecycle submissions
- Strong knowledge of global health authority and ICH regulations and guidance as it pertains to format and submission structure.
- Current knowledge of CBER/CDER regulatory technical requirements
- Proficiency with MS-Office Suite and Adobe Acrobat, including pdf plug-ins that support submission readiness
- Experience with document management and Regulatory Information Management Systems (RIM)
- Broad technical knowledge (MS Word, Adobe Acrobat PDF Bookmarks and Hyperlinks, Acrobat Plug-ins, Document Management Systems, Excel, ISI Toolbox, Lorenz)
- The individual must be able to maintain the security of confidential information
- This position reports functionally to a RDE publishing Manager.
- This position is office-based work at Global Business Solutions Center (GBS) based at Cork, Ireland.
- The shift for the position is Monday through Friday, 8 hours a day.
- Some overtime may be required.