Regulatory Affairs Executive

The job holder is responsible for managing the renewal of company and product licenses with relevant government agencies, including product registration with the National Pharmaceutical Regulatory Agency (NPRA). He/She will ensure full compliance with local regulatory requirements and monitor new laws and regulations, providing the Management Team with up-to-date information to mitigate business risks.

Responsibilities

• Manage regulatory affairs including product registration and legal requirements.
• Prepare product classification, labeling and maintain SDS (safety data sheet) in compliance with CLASS regulation.
• Scheduled Waste Management
• Timely reporting to relevant authorities (CIMS, eSWIS, CWC, Feed Act & Poison Act, etc.).
• Work closely with manufacturers / principals / suppliers to prepare and obtain relevant documentation and information on products complying to Legal Requirements.
• Conduct training from time to time to staff on necessary skills and knowledge to ensure regulatory compliance in their daily work activities.
• Develop work procedures whenever necessary to ensure regulatory compliance in their daily work activities.
• Maintain and update the Product Master List, SDS for all current active products.
• Check Shipping Schedule and apply necessary Import / Export Permits / Approvals to facilitate smooth exportation / importation processes.

Qualifications

• Degree in Pharmacy or Chemistry or equivalent.
• At least 2 – 3 years’ experience in the Chemicals industry / distribution environment.
• ISO Awareness or Quality Management Training Certificate
• ISO Auditor Training Certificate
• Possession of a valid pharmacist license will be an added advantage