Job Description

RESPONSIBILITES

• 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.

• 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.