Coordinate & consult with other departments on the content, review & assembly of regulatory documentation.
Ensure consistency, completeness, & adherence to MOH/FDA/EU standards for all regulatory submissions.
Critically review protocols, data & reports to ensure the clarity, consistency, & conformance to regulations, guidelines & regulatory strategy as well as suitability for submission to regulatory agencies.
Prepare & submit reports to the QA manager, as required.
Provide leadership & QA manager with current Good Manufacturing Practices (cGMPs), government regulations, industry standards, approved specifications, and company procedures and directives.
Identify & resolving quality problems.
Reviewing documentation for compliance with GMP.
Managing customer queries and complaints.
3 years working in pharmaceutical science.
3 years work experience with FDA / EU & GMP regulations & quality system.
Strong interpersonal communication skills must have strong analytical and technical writing skills.