About our client
Our Client operates in the Pharmaceutical Manufacturing Industry, with its headquarters rooted strongly in Singapore. It has its branches spread to more than 5 countries, providing employment to 250 people. Their core business is to represent their client in countries that they do not operate in, and market/sell their products for them. They have achieved a wide client base in a very short time, and are looking for new talent.
- 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.
- 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