Assist in timely product registration and variation submission via NPRA Quest system for pharmaceutical products.
Assist in timely product notification submission via NPRA Quest system for products, product notification maintenance and document retention.
License application and maintenance.
Liaise with local Regulatory Authorities to expedite early regulatory approvals while developing and serve as the official and full time liaison personnel with the government's regulatory agencies and Ministry of Health.
Ensure proper documentation of all regulatory applications and communications with clients & Regulatory Authorities
To assist RA/QA on daily activities ranging from regulatory, quality, compliance and provide regulatory support internally
To support customers' enquiries/ requests in relations to Regulatory and Registration.
Contact person of any queries pertaining to registering and maintaining products license, product complaints, recalls and renewal from regulatory authority officials, respond and attend to queries posted by regulatory authorities in a timely manner.
Participate in new product development, quality assurance, manufacturing and marketing team projects as to ensure all practices and outcomes are complied with regulatory requirements.
Job Type: Full-time
Education:
* Bachelor's (Preferred)
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