Job Details

Responsible for supporting all aspects of regulatory compliance, submission preparation, and product lifecycle management under the direction of the department management. This role also provides cross-functional support to ensure compliance with pharmacovigilance (drug safety) reporting requirements in accordance with FDA and global regulatory standards. Activities may include but are not limited to: - Compilation/review of original applications (IN - Ds, ND - As, AND - As), amendments, supplements, annual reports and product labeling in accordance with FDA and ICH guidelines. - Assessment of regulatory impact of proposed changes to manufacturing facilities and processes. raw material sources, packaging components, and/or controlled documents. ROLES & RESPONSIBILITIES:Product support activities: Compilation and review of FDA Submissions (e.g., NDA/ ANDA Filings, Amendments, Supplements, Annual Reports, DMF Updates, labeling packages) as agreed upon with change control review/approval ...Regulatory Affairs, Regulatory, Specialist, Senior, Project Management, Healthcare, Business Services, Reports