Agensi Pekerjaan & Perundingcara Bright Prospect Sdn Bhd Vacancies Regulatory Affairs, Senior Associate (MNC Pharmaceutical)
Agensi Pekerjaan & Perundingcara Bright Prospect Sdn Bhd is looking for new potential candidates to fill in for Regulatory Affairs, Senior Associate (MNC Pharmaceutical) position. If you currently looking for new healthcare job opportunities and qualified with the job desc, feel free to apply this job.
Job Description
- Handle/supports products registration and license maintenance.
- Responsible to Malaysia, Singapore & Brunei countries and some APAC coordination works
- Monitor product registration status and ensure the validity of registrations
- Monitor and disseminate information on changes to medical device laws & regulations affecting registration, manufacture, distribution, and sale & marketing of company products for assigned geographies / competent authority.
- Assist in reviewing regulatory documents and materials such as package inserts, labels, and other packages.
- Participate in Marketing material development by offer insights from a regulatory perspective.
- Maintain regulatory database and report regularly.
- Keep up to date with any new directive or notice issued by National Pharmaceutical Regulatory Agency (NPRA)
- Update product registry into system and trackers
- Other regulatory tasks as assigned
- Candidate must possess at least a Diploma, Advanced/Higher/Graduate Diploma, Bachelor's Degree, Post Graduate Diploma, Professional Degree, Master's Degree, Medical Science, Pharmacy or equivalent.
- At least 2-3 years of working experience in Regulatory Affairs with NPRA & HSA for submission
- Meticulous with multi-tasking ability and organized
- Proficient in Microsoft Office applications especially Excel files
- Confident, mature, resourceful with a pleasant personality
- Able to work independently with minimum supervision
- Good communication skills with possess good oral and written skills. Proficiency in English is essential.
Company Overview
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