Regulatory Affairs Exec | $3500 +++ @ Macpherson
The Regulatory Affairs (RA) Executive is responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. Assist to develop procedures to ensure regulatory compliance as and when required.
- 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 by RA Supervisor or Business Development Director
- 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.
For interested applicants, please email your UPDATED CV in Microsoft Word format to [Click Here to Email Your Resume]. Your interest will be treated with strict confidentiality.
We regret only shortlisted candidates will be notified.