Commercial Regulatory Affairs Manager

at  LABGISTICS ASIA PTE LTD

REQUIREMENTS:

• Degree in Medical Science or related discipline
• Pharmacy Degree registered with Singapore Pharmacy Board
• At least 4 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.
• Working experience as Pharmacist for at least 3 years
• Well verse on Power point presentation.
• Business engagement under Regulatory Affairs is an added advantage.
• Experienced on HSA audits and knowledge on ISO13485, ISO90001 and SS620 are an added advantage.
• Knowledge on secondary redressing is required.

• Lead and supervise the SG Regulatory Affairs (RA)
• Accountable for all permit & licenses application, renewals, and maintenance under the company
• Accountable for all Products Registration, renewals, and amendments
• Guide and train the Regional Regulatory Affairs team on the preparation of documents for license applications and maintenance.
• 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.
• Ensure the compliance of our Standard Operating Procedures (SPs/SOPs/WIs) in accordance with local regulations & certified bodies standards.
• Attend to all regulatory matters relating to the sales and distribution of Medical Devices, Radioactive Therapeutic Products, Controlled Drug and Therapeutic.
• Submission of reports and transactions of our companies’ assigned licenses and permits required by respective.
• Participate in meetings with the local Regulatory Affairs team to review status of registrations, renewals and amendments including projects and other activities of the department.
• 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.
• Carry out any other duties assigned from time to time by the Director or Business Manager/General Manager