Job Details
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Job Description
- Researching, analyzing and interpreting regulatory rules and guidelines
- Preparing, compiling and submitting documentation to regulatory agencies
- Tracking and ensuring timely responses to regulatory agency queries
- Reviewing product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies
- Maintaining current knowledge base of existing and emerging regulations, standards, or guidance documents
- Interpreting regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures
- Providing support to the operational teams in the development of procedures and systems to ensure regulatory compliance •
- Interacting with regulatory agencies and represent the company during regulatory inspections
- Providing regulatory input to product lifecycle planning
Job Requirements
- Develop and implement internal regulatory policies and procedures
- Prepare and submit documentation to regulatory agencies
- Communicate with regulatory agencies regarding submissions, compliance issues, and audits
- Monitor and analyze regulatory affairs trends and changes • Provide guidance and advice to other departments on regulatory requirements
- Ensure company compliance with all regulations and laws pertaining to company business
- Conduct internal audits to assess compliance with regulatory requirements
- Prepare and present compliance reports to internal management and regulatory agencies
