Job Title

7 days ago

Singapore CADENCE GROUP PTE. LTD. Full time

Job Responsibilities:

- Work closely with the supplier/manufacturer and regulatory authorities/bodies regarding product submissions and compliance.
- Prepare product technical dossiers for regulatory submission for both new products and existing product’s variation.
- Liaise with relevant parties to resolve product registration and regulatory issues.
- Ensure all required procedures and documentation for product variation/new product registration are promptly performed.
- Notify and update Health Science Authority (HSA) of any change of particulars/documents related to product registration on a timely manner.
- Maintain document control of technical file, quality procedures and work instructions for the purpose of product registration and to support audits.
- Keep track of changes in country’s regulatory requirements and provide regulatory intelligence to management and Business Development and Sales team.
- Support in the maintenance of the Quality Management System to comply with GMP/GDP requirements and international regulatory requirements.
- Maintenance of HAS importer license, wholesale license and other licenses for business operation.
- Oversee Pharmacovigilance - reporting of adverse reaction, adverse event and post marketing related activities to product owner and regulatory authorities.
- Any other ad-hoc duties as and when assigned

Job Requirements:

- Degree in Pharmacy, Medical Science or equivalent.
- At least 2 to 3 years of regulatory affairs experience in a pharmaceutical company. Those with a Singapore Pharmacist license is preferred.
- Good knowledge and understanding of the HSA’s rules and regulations.
- Must be meticulous with good organization and time management skills.
- Possess good communication and interpersonal skills with

Able to work independently and tight deadlines

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