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. It involves submission filing and archiving expertise in the acquisition, quality control, retention, and submission of nonclinical and clinical regulatory documents and other sponsor-specific essential documents, including but not limited to ANDAs, NDAs, annual reports, responses to information requests etc. The incumbent helps the company document its compliance with relevant health authority requirements (Food and Drug Administration (FDA), European Medicines Agency (EMEA) and others), using Good Clinical Practice (GCP) and ICH guidelines, company Standard Operating Procedures (SOPs), and other directives.
- Assess quality and delivery of Dossier Plans, quality of deliverables and timelines against established KPIs
- Establish Dossier Plans for the assigned Global submission
- Prepare, review and submit pre- and post-approval submissions to FDA in accordance with appropriate guidelines and regulations (21 CFR)
- Ensure distribution in compliance with due dates to Health Authorities and/or Local Operating Companies, as applicable, tracking submission events/activities in appropriate systems/tools
- Generate dossier plans that will reflect inputs from functional area representatives and key stakeholders
- Support development of departmental work practices, process enhancements, and associated training materials
- Develop/maintain associated process tools and relevant training documentation and keep up to date with regulatory guidelines
- 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
Eligibility: A Bachelor’s degree in Scientific discipline (preferably Chemistry or pharmaceutical), Certificate or Master’s degree in Regulatory Affairs (preferred, not required).