Regulatory Compliance Assistant Manager cum Pharmacist
Biomedia Holdings Pte Ltd, Singapore

• Lead and supervise the SG Regulatory Affairs (RA) Team (Singapore Team Lead)
• Accountable for all permit amp; licenses application, renewals, and maintenance
• 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
• Main liaison for inter-department (including regional) alignment of work processes/ procedures as required
• Attend to all regulatory matters relating to the sales and distribution of our regulated products
• Accountable for internal control functions of each transaction in accordance with regulatory requirement, review that CAPA reports are aligned with best practices and that corrective actions are completed
• 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 amp; certified-bodies standards
• Assist the reporting manager align Regulatory Affairs budget including reporting of discrepancies
• Any other ad hoc duties pertaining to regulatory affairs Permit amp; Licenses application and maintenance

Key Notes:

• Assumes the role as our Principal Pharmacist license holder
• Assumes the role of a National Responsible Person Pharmacovigilance (NRPP) for our applicable Therapeutic Products: -

• Ensure proper reporting and documentation of quality complaints, ADRs, AEs, special situation, medical enquiries, and clinical activities to principal’s drug safety unit as well as local regulatory authorities in applicable territories
• Conduct PV training to staff on any suspected PV cases relating to applicable therapeutic products
• Provide regular individual case safety report (ICSR) to principal

Benefits

Requirements

• Degree in Medical Science or related discipline
• Pharmacy Degree registered with Singapore Pharmacy Board
• Familiar with the registration requirements for Form A Poison License and Controlled Drug License / Medical Devices / Therapeutic Products
• Able to communicate fluently in written and verbal English
• Working experience as Pharmacist for at least 2 years

Job Rewards and Benefits