Regulatory Affairs Manager – Pharmaceutical

Job Title:	Regulatory Affairs Manager – Pharmaceutical
Experience:	5 to 7
Location:	Egypt, Cairo
Category:	Medical/Healthcare, Quality, Pharmaceutical
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.
Qualifications:	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
Contact:	Apply

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