- 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.
- Prepare and put forward all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, incompliance with regulatory standards.
- Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
- Develop regulatory strategies and implementation plans for the preparation and submission of new products files.
- Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
- Manage activities such as manufacturing site audits, regulatory agency inspections, pharmacovigilance, or product recalls.
- Align Regulatory Affairs planning with business strategy and commercial objectives to ensure full synchronization and harmony.
- 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 business development, marketing, and senior management.
- Interpreting both scientific and legal documents.
- Obtaining regulatory authority for all marketing materials.
- Suggest solutions for process improvements.
- Identify process bottleneck and implement solutions in a timely manner.
Previous working experience in Regulatory Affairs for 1 - 2 years.Has Certificate of Attendance for CTD/eCTD and worked with it at least 1 year Sense of ownership and pride in his performance and its impact on company’s successCritical thinker and problem-solving skillsTeam player.Good time-management skills.Strong interpersonal and communication skills.Excellent commend of computer skills.