Our client is looking for a part-time Regulatory Affairs Executive (Registered Pharmacist), whom is able to work on a part-time basis for 2-3 days per week.
Responsibilities
- Accountable for all permit & licenses application, renewals, and maintenance under the company
- Accountable for all Products Registration, renewals, and amendments
- Communicate with regulatory authorities as well as regional RA team regarding regulatory affairs matters such as product registrations, changes in existing products and renewals.
- Advise internal stakeholders on regulatory guidelines and be responsible for new product registration and license renewal progress.
- Be the main liaison with regulatory and government bodies regarding Regulatory Affairs
- Be the main liaison for inter-department alignment of work processes/procedures as required.
- Responsible for local permit & licenses application, renewals and maintenance
- Review and prepare product dossiers for submission including variations (therapeutic products, medical device etc.)
- Maintenance and filing of current product licenses and registration documents.
- Liaise with QA and Operations on the periodic and routine review of logs and records for movement and traceability of products.
- Submission of reports and transactions of our companies’ assigned licenses and permits required by respective.
- Participate in all RFQ/RFI and able to provide guidance to all potential clients with regards to registrations, requirements, timeline, pharmacovigilance, etc.
- Familiar with HSA requirements and Guidelines.
Requirements
- Singapore Registered Pharmacist
- At least 2 years related experience
- Familiar with the registration requirements for Form A Poison License and Controlled Drug License / Therapeutic Products / Medical Devices
- Able to communicate fluently in written and verbal English
For more information, please apply with your updated CV (in Word document).
Ambrose Chan
Registration Number: R1218177
EA License Number: 17C8502
