Job Details

Responsible for support of regulatory affairs activities under direction of department management. Activities may include but are not limited to: Compilation/review of Annual Reports, original applications, amendments, and supplements and product labeling. Assessment of proposed changes to manufacturing facilities, processes, 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 and management. QUALIFICATIONS: Bachelor's degree in a scientific area of interest required (e.g., chemistry, microbiology/biology, pharmacy, premed, nursing). Minimum of two years of experience plus a Regulatory Affairs Certification or four years of direct pharmaceutical industry experience or solid equivalent work experience in a cGMP and/or FDA regulated environment. KNOWLEDGE, SKILLS AND A...Regulatory Affairs, Regulatory, Associate, Senior, Project Management, Business Services, Staffing, Skills