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.

Pharmacovigilance Specialist Jobs in Egypt .css-uzlk74{font-size:14px;font-weight:400;font-style:normal;letter-spacing:-0.35px;line-height:22px;margin-left:8px;}1 Jobs found

.css-o171kl{-webkit-text-decoration:none;text-decoration:none;color:inherit;}Regulatory Affairs Specialist Pharmacist

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Pharmacovigilance Specialist Jobs in Egypt 1 Jobs found

Regulatory Affairs Specialist Pharmacist