This position is responsible for the management and delivery of regulatory submissions to health authorities required to support the maintenance, development and registration of products. The Regulatory Operations Specialist provides submission filing and archiving expertise in the acquisition, quality control, retention, and submission of nonclinical, Chemistry, Manufacturing Control (CMC), and clinical regulatory documents and other sponsor-specific essential documents. The incumbent performs document formatting, document and sequence level publishing, manages document workflows, maintains files, assures completeness of the records, and helps the company document its compliance with relevant health authority requirements (e.g. Food and Drug Administration (FDA), European Medicines Agency (EMEA)), by the principles of Good Clinical Practice (GCP) (e.g. ICH Guideline E6), company Standard Operating Procedures (SOPs), and other directives.
Responsibilities include –
- Establishing Dossier Plans for the assigned Global submission.
- Generating dossier plans that will reflect inputs from functional area representatives and key stakeholders.
- Assess quality and delivery of Dossier Plans, quality of deliverables and timelines against established KPIs.
- Ensuring relevant submission process(es) are applied to all assigned submissions, including coordinating the electronic component and dossier level publishing and production of regulatory submissions that conform to regional and country specific regulatory requirements as appropriate.
- Ensuring dispatch/distribution in compliance with due dates to Health Authorities and/or Local Operating Companies, as applicable, tracking submission events/activities in appropriate systems/tools.
- Support development of departmental work practices, process enhancements, and associated training materials.
- Develop/maintain associated process tools and relevant training documentation.
- Support compliance needs as appropriate.
- Apply appropriate regulatory submission standards, requirements, processes and policies to comply with applicable health agency requirements;
- Maintain open, timely and effective communications with all publishing contributors and responsible RA professional, to ensure timely delivery of dossier components and/or complete dossier for submission;