Regulatory Pharmacist

MAIN FUNCTIONS:

• Form A license holder and other license as required by regulatory.
• Liaise with regulatory body regarding pharmaceutical compliance affair.
• To update local and overseas countries on regulatory requirement for implementation.
• Involved in day-to-day pharmaceutical manufacturing operations and ensure compliance to PIC/S GMP standard.

RESPONSIBILITIES:

• To assist in maintenance of product license with local and overseas authority.
• To prepare product registration dossier for local and overseas market.
• To assist in regulatory audits and response to the authority query.
• To assist post-marketing product query or correspondence and work closely with QA/QC department pertaining to product quality issue.
• Responsible for all dispensing materials and activities to use in production.
• Maintenance of controlled drugs and records, including the storage and sale.
• Review and update SOP relating to the production periodically.
• Handling and managing of production issue raised by the production team.
• Provide training to production staff on SOP and cGMP.
•  Work closely with QA/QC department to maintain cGMP standard.
• Be involved in other company projects.

REQUIREMENTS:

• Candidate must possess at least Bachelor's Degree of Science (Pharmacy).
• At least 2 Year(s) of working experience in the related field is required for this position.