Regulatory Affairs Pharmacist

1 week ago


Singapore Pharmaforte Singapore Pte Ltd Full time

Job Description: Ensuring timely regulatory submissions for new products, indications, renewals and variations to maintain current registration of all products. Liaising with and ensuring compliance with HSA as well as Principal's requirements pertaining to post-market activities. Review and approval of advertising and promotional materials. Ensuring compliance with HSA requirements for Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and Good Distribution Practice for Medical Devices in Singapore (GDPMDS). Participate in the maintenance and improvement to the company's Quality Management System, including Management Review. Supports RA/QA Manager for Internal and External Audits. Ensure compliance with Principal's Quality Agreement. Serve as the Deputy Pharmacovigilance (PV) contact between the company, HSA, and principals, to support the maintenance of the company's Pharmacovigilance system in accordance with local and principals' requirements. Conduct training for Standard Operating Procedures (SOP) and PV compliance. Provision of adequate and relevant medical information. Responsible for timely and accurate tender submissions, maintain oversight and management of tender portfolio. Skills and Qualifications: Degree in Pharmacy Registered Pharmacist with the Singapore Pharmacy Council Strong attention to detail, well‐organised with problem‐solving skills. Good written / verbal communication skills Team player MS Office Preferably minimum 1-2 years of experience in regulatory submissions, quality system & assurance will be advantageous. Knowledge of GxP such as Good Manufacturing Practice (e.g. PIC/S) / Good Distribution Practice / Good Pharmacovigilance Practice, SS620 Good Distribution Practice for Medical Devices / ISO13485#J-18808-Ljbffr



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