Manager, Regulatory Affairs
Salt Lake City, UT 84101 US
Under general direction, responsible for successfully filing original Abbreviated New Drug Application submissions and for managing changes requiring regulatory submissions. Can be primary contact with regulatory authorities for assigned projects and products. Determines nature and scope of information to be generated to ensure comprehensive filings for FDA review (ANDAs, deficiency response amendments, TA to FA amendments, post-approval supplements). Keeps Company informed of significant regulatory issues that affect assigned products/projects.
Essential Duties & Responsibilities:
- Carries out managerial responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.
- Prepare, review and approves regulatory submissions (i.e. ANDAs, amendments, supplements, etc.) to the Food and Drug Administration (FDA) to ensure compliance with applicable regulations and guidance.
- Effective at prioritization across many projects (5 – 15) including early stage research and development, filing phase, deficiency rounds, and post-approval.
- Assess risks throughout R&D, filing, deficiency rounds and post-approval and documents these risks appropriately
- Escalates project issues and risks to management appropriately
- Leads preparation meetings for FDA. For example, leads in defining questions and all supporting information for Pre-ANDA meeting with FDA for complex projects.
- Leads deficiency response meetings: defining scope, deliverables, and response strategies
- Reviews and approves change notices, specifications, batch records, standard test
- methods, etc.
- Implements policies to assure on-going compliance of Regulatory Affairs activities.
- Assesses impact of new regulations and suggests appropriate changes to business
- processes/policies as necessary.
- Proposes new efficiencies for client RA department’s day to day practices
- Interacts with the FDA to facilitate approval of the regulatory submissions.
- Maintains awareness of all regulatory activities on assigned projects.
- Works to minimize regulatory issues and helps prevent unnecessary regulatory delays.
- Performs related duties as assigned.
- Bachelors of Science Degree from an accredited college or university
- Preferred MS or other advanced degree
- 6+ years related regulatory experience with a pharmaceutical company
- Experience Preferred: Development of both complex and non-complex generics across a multitude of dosage forms including combination products
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