Regulatory Affairs Assistant

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

Regulatory Affairs Associate

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