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Regulatory Affairs Manager - Pha...

STIO Life Science - Cairo, Egypt

Regulatory Affairs Manager - Pharmaceutical

STIO Life Science - Cairo, EgyptPosted 2 months ago
74Applicants for1 open position
  • 9Viewed
  • 2In Consideration
  • 10Not Selected

Job Details

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Job Description

  • Establish procedures or systems for publishing document submissions either in hardcopy or electronic formats.
  • Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.
  • Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
  • Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
  • Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.
  • Develop regulatory strategies and implementation plans for the preparation and submission of new products.
  • Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
  • Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
  • Manage activities such as audits, regulatory agency inspections, or product recalls.
  • Establish regulatory priorities or budgets and allocate resources and workloads.
  • Provide responses to Regulatory Agencies regarding product information or issues.
  • Align Regulatory Affairs planning with business strategy and commercial objectives to ensure full synchronization and harmony.
  • Coordinate QPPV related tasks and responsibilities.
  • Develop and maintain standard operating procedures or local working practices.
  • Maintain current knowledge of relevant regulations, including proposed and final rules.
  • Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
  • Oversee documentation efforts to ensure compliance with domestic and international regulations and standards.
  • Writing evidence-based reports on a new product.
  • Writing executive summaries of new or changing regulations.
  • Interfacing between R&D, marketing, and senior management.
  • Interpreting both scientific and legal documents.
  • Developing regulatory strategies and implementation plans for new products.
  • Overseeing product trials and regulatory inspections.
  • Obtaining marketing permission for a new product.
  • Outlining requirements for a product’s labeling, packaging, and storage.
  • Writing concise, clear, and informative product information leaflets.
  • Overseeing the completion of all regulatory compliance documents.

Job Requirements

  • Sense of ownership and pride in your performance and its impact on company’s success
  • Critical thinker and problem-solving skills
  • Team player.
  • Good time-management skills.
  • Strong interpersonal and communication skills.
  • Bsc. in Pharmaceuticals.
  • Preferably hold MBA 

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