7 months ago
Job Title: Manager-Associate Director, Regulatory Operations
Job Location: New Jersey, in office 2 days a week
- Publishing of all submission source documentation as well as submission dossier compilation and dispatches to Health Authorities via Freyr Submit Pro and Veeva RIM.
- Manage IND filing and maintenance activities as the Regulatory Operations Lead.
- Accountable for all Publishing activities, verification, dispatch and management of major and routine submissions in e-CTD format.
- Responsible for planning, preparing, tracking, and archiving regulatory documents and submissions.
- Responsible for setting up kickoff meetings and setting timelines for major submissions
- Adherence to required submission timelines, health authority publishing specifications, and internal working practices.
- Partner with subject matter experts in Regulatory Affairs, Clinical Operations, Medical Writing, and Drug Safety to develop and implement processes supporting document authoring, submission compilation archival, and planning and tracking of regulatory submissions and health authority interactions
- BA/BS degree or equivalent
- 4 years of eCTD publishing and submission experience in pharmaceutical industry.
- Knowledge of health authority procedures/guidance regarding electronic submissions.
- Knowledge of IND, NDA, MAA, CTD requirements and guidelines.
- Technical knowledge of electronic publishing systems and software. Experience with Veeva RIM and Freyr Submit Pro is a plus
- Vaccinated against Covid-19