jobs in SM PHARMACEUTICALS SDN BHD

Kerja Sepenuh Masa Registration Officer, Gaji tinggi MYR 3,000 di SM PHARMACEUTICALS SDN BHD Kedah - Maukerja

Kongsi
Simpan

Lokasi Kerja

  • Sungai Petani Kedah Malaysia

Penerangan Kerja

Tanggungjawab

Job Description

  • Prepare, compile, review and submit product registration and variation applications to the relevant regulatory authorities (e.g., NPRA).
  • Monitor the status of product registrations, renewals, amendments and variations. Ensure all product registrations are maintained in compliance with current regulatory requirements.
  • Liaise with regulatory authorities regarding product registration matters and respond to queries promptly. Coordinate with internal departments such as R&D, Quality Assurance, Production, Purchasing, Marketing and Sales to obtain required documentation.
  • Review product labels, packaging artwork and product information to ensure regulatory compliance. Maintain accurate regulatory documentation, databases and product registration records.
  • Keep updated with changes in pharmaceutical regulations, guidelines and industry requirements. Support audits and inspections by preparing regulatory documents when required. Assist in preparing Standard Operating Procedures (SOPs) related to regulatory activities. Perform any other duties assigned by Management. Export market Regulatory work and product registration process also having understanding on eCTD.
  • JOB REQUIREMENTS
  • EDUCATION
  • Bachelor's Degree/Diploma in Pharmacy, Pharmaceutical Science, Chemistry, Biotechnology, Life Sciences or a related field.
  • EXPERIENCE
  • Minimum 2 years of experience in pharmaceutical regulatory affairs or product registration. Fresh graduates with relevant internship experience are encourage to apply.

Pay: RM1,800.00 - RM3,000.00 per month

Benefits:

  • Meal allowance
  • Professional development

Work Location: In person

Peringatan Penting

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