Regulatory Affairs Pharmacist

5 days ago

NorthEast Region, Singapore Pharmaforte Singapore Pte Ltd Full time $80,000 - $120,000 per year

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

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