Regulatory Affairs Manager

3 weeks ago

Princeton, United States eTeam Full time

Job Title: Regulatory Affairs Manager Location: Princeton, NJ 08540 Duration: 6+ Months

Duties:

**Can be hybrid, but this role will be mostly onsite in Princeton, NJ. Local candidates.** Supports regulatory affairs projects to organize, analyze, identify, track and resolve submission and filing issues, and maintain compliance Suffixes naming Compliance SPIRIT communications FDA meetings, BLA etc Annual reports BLA Annual Report preparation/ submission DSUR DSUR US regional appendices responsibility Support QA/PV/FDA audits Lot Distribution Reports Submissions: sBLA CClient, Client, CBE-0/30 Review submissions prior to dispatch Post Marketing label updates where applicable Contribute US labeling and artworks preparation Organize and liaise SPL creation for submissions impacting labeling Understand US environment guidelines, policies, precedents SOPs : Comply with Sandoz SOPS Request NDC codes Country of origin determination Alignment with legal Drug listing requests upon submission approval Monitor reference product labeling updates Product samples shipment to FDA - manage documentation for customs, shipment invoicing and handle returned samples for destruction Environmental Analysis by gathering 5 years of DS usage forecast BsUFA fees management and survey Submit archival requests for FDA correspondences Distribution Data - Lot Distribution Report submission every 6 months by gathering supply information and requesting SPL conversion of received data Skills: Experience with supporting FDA submissions from an operational perspective. Experience with Sandoz/Client systems a plus. Comprehend science, organizational skills, able to multi task, problem solve work in a matrix environment. At least 3-5 years of related RA manager experience Education: Bachelor's degree required. Degree in Science highly preferred.

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