To track and oversee Regulatory Projects & Timelines using Microsoft Project Management Software; to monitor potential bottle necks and to highlight to Supervisor to devise resolution methodology.
To research and obtain regulatory information from Authorities, Associations and Consultants for existing countries or new emergent countries and present findings and recommendation in reportable format.
To communicate timely and clearly on documentation requirements for regulatory submissions for new / variation / renewal registrations with stakeholders; to review and compile dossier package for second review by Supervisor and to rectify issues before official submission.
To monitor, follow up proactively & accountable on status of submitted Regulatory Projects with external Consultants/Distributors to pre-empt issues to drive timely/early regulatory approvals.
To research and furnish write-ups / reports to overcome administration / safety / efficacy clarification issues on submitted Regulatory Projects from Regulatory Authorities.
To prepare regulatory dossier as per ACTD / required format from Authorities. To prepare and review Quality portion of dossiers for submission.
To ensure current information are updated and maintained in the Regulatory Tracking Master List and database IIMS; to enable accurate information to be extracted and presented in reportable format.
To perform labeling checks and highlighting discrepancies against stipulated label requirements of the respective country of export and import and/or inconsistency with other markets.
To assist in QA function to ensure Regulatory registration projects are being achieved.
To assist in QA function to support QA department, where necessary.
ACADEMIC QUALIFICATION / TRAINING / EXPERIENCE REQUIRED
A good Degree in Chemistry/Pharmacy/Microbiology/Science.
Minimum 3 years of relevant working experience in Regulatory environment for health product or OTC pharmaceutical products.
Familiar with ASEAN Regulatory guidelines.
A leader with good analytical skill, good application knowledge and experience, and good communication and interpersonal skills.
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