Regulatory Affairs Specialist

Special Med -
Nasr City, Cairo

Special Med -
Nasr City, CairoPosted 19 days ago

44Applicants for1 open position

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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 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