
Regulatory Affairs Assistant
6 days ago
Responsibilities
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Support Regulatory Officer in processing over-all legal requirements of the company activities such as production registration, renewals, variations, and other regulatory concerns.
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Assist in liaising with regulatory authorities and ensuring that the quality standards are met, and submissions meet strict deadlines.
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Provide assistance in maintenance of regulatory files
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Keeping up to date with changes in registration and guidelines
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Help monitor status of registrations and other regulatory applications
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Assist with FDA and other government inspections or audits
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Collaborate with Sales & Marketing Team for the new product being developed.
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Communicate with global supplies to request for legal & technical documents needed for product registration.
Qualifications
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On-site
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Full Time
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College Graduate, preferably Pharmacy major
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Has knowledge or familiarity in FDA regulations or experience in Regulatory Affairs
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Can understand minimal medical terminology.
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Has strong communication, research and organizational skills.
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