Regulatory Affairs Pharmacist - #1123400

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