Regulatory Affairs Specialist (Pharma) - Singapore

Responsibilities:

• Negotiate with local authorities on behalf of company objective. Act as the key person to communicate and negotiate with local regulatory authorities.
• Coordinate efforts associated with the preparation of regulatory documents or submissions.
• Prepare and submit all the required product registration documents and other relevant license application.
• Notify and update Health science Authority (HSA) and/or local country product registration of any change of particulars / documents related to product registration.
• Manage adverse event and field safety corrective action reporting to HSA and/or local country product registration within the stipulated timeline.
• Ensure changes to the approved products are timely submitted to HSA and/or local country product registration as required.
• Maintain product registration record and product registration database to ensure proper documentation and record filing.
• Maintain QMS (e.g. Good Distribution Practice for Medical Devices, GDPMDS) and implement any changes required including training and communications with affected parties.
• Responsible for all quality control duties such as establishment, verification and implementation of all quality control procedures in respect of quality system to comply with all statutory GMP & ISO standards.
• Handle product complain, reporting adverse events and recall to the local regulatory authorities as required.
• Create training materials and train employees to improve regulatory skills in local office or region and at our manufacturers, where applicable.
• Support in both internal /external QMS audit.

Requirements:

• Degree in Pharmacy with a valid Singapore pharmacist licence
• At least with 2 years working experience in Regulatory Affairs in Pharmaceutical, Experience in Pharmaceutical, Nutrition and Medical Device will be an advantage.
• Good written and verbal communication skills