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
Develop and implement internal regulatory policies and proceduresPrepare 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