Unimed Sdn Bhd is looking for new potential candidates to fill in for REGULATORY AFFAIRS EXECUTIVE position. If you currently looking for new healthcare job opportunities and qualified with the job desc, feel free to apply this job.
- Ensure submission and approvals for product registrations or variations (Schedule Poisons, OTC, and Health Supplements) are carried out in a timely manner in compliance with internal and external regulatory requirements.
- Responsible to review new preliminary and concept formulas to determine ingredients acceptability and appropriate product classifications.
- Renewals of product registration as planned and regulatory data are updated.
- To liaise with relevant authority in all the matters regarding to product registration.
- To ensure the content of packaging and other materials are compliant with local regulations.
- Responsible for product complaint from NPRA and liaise with manufacturer regarding the CAPA.
- To ensure good housekeeping and those up-to-date regulatory documents is maintained in hardcopy and softcopy.
- Maintain professional relationship with Health Authorities and players of similar industry.
- Occasionally undertakes other duties not specified above, as and when required from time to time.
- Candidate must possess at least a Bachelor’s Degree in Pharmacy / Pharmacology, Medicine, Bio-Medical, Biotechnology, Chemistry, Biology or equivalent.
- At least 3 year working experience in product submission and registration of schedule poison, OTC, health supplement or traditional medicine with NPRA.
- Experience in vaksin and biological registration
- Candidate with QA/QC and manufacturing background will be an added advantage.
- Positive working attitudes, teamwork spirit, have sense of urgency, self-initiative, self-discipline and have eyes-in detail
- Posses own transport
- Fluent speaking and writing in English & Bahasa Malaysia.
- Permanent position(s) available.
How To Apply
If you confident and feel that this job is suitable to you, go ahead take your action now.
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