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Regulatory Specialist
Great opportunity ro join Global Pharmaceutical Company! Description: • The Regulatory Specialists responsibilities will include, but not be limited to, the following: • Supports members of PC in addressing any issues that may arise with promotional materials or submissions. Follows-up with the Reviewer to ensure issues are resolved. • Independently performs a Quality Control (QC) review of promotional materials scheduled for submission to OPDP, either electronically or manually as appropriate, in addition provides QC to regulatory documents such as ISIs, PIs, and Brief Summaries prior to Regulatory final approval. Notifies appropriate PC member of any discrepancies and resolves issues with appropriate marketing point. • Prepares Form FDA 2253 submission packages and assists in finalizing final submission binders for advisory comments. Aligns with the submissions teams to ensure submission packages are reviewed and finalized for proper submission through the electronic gateway • Responsible for Maintaining/updating Document Repository for archiving and tracking documents to ensure timely and accurate retrieval of information upon request, e.g., in the event of an audit or reviewer request of materials. • Itemize and archive printed promotional material with Iron Mountain • Acts as liaison between Brand Coordinators as well as Review Managers to make sure databases are accurate and up to date and there is alignment between review and approval systems and document repositories. • Attends PRC meetings for assigned brands during non-submission days to track promotional material in the pipeline • Maintains flexibility and willingness to perform other duties as required.
Qualifications: Education: requires a Bachelors degree in science, Pharmacy or related field Minimum of 2-5 years of pharmaceutical experience (either in a submissions or administrative role) - Knowledge or exposure to pharmaceutical compliance - Project coordination and good communication with internal stakeholders - Document repository experience (SharePoint, etc.) - Good technical working knowledge of computer system