Skills And Tools:
- 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.
- 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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