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Regulatory Specialist
2 months ago
Job description
Regulatory Specialist
1. Food Registrations (FDA) – review and preparation of documents and actual sample for submission
· Initial Applications
· Renewal Applications
· Reapplications (submissions with compliance)
2. LTO (FDA) – communicate with front end staff regarding FDA concerns
· Initial Applications
· Renewal Applications
· Variations (Notice of Change of Pharmacist, transfer of location)
· CAPA (compliance during inspection)
3. Attend meetings/seminars within and outside the organization as advised by the immediate superior
4. Assist customers / inform product knowledge if needed
REQUIREMENTS / QUALIFICATIONS
· Ability to work efficiently in a high-pressure, fast-paced, deadline-driven environment.
· Good written and verbal communication skills.
· Excellent people skills to interact with colleagues
· FDA Guidelines
·BS PHARMACY Graduate
·Pharmacist’s Licensure Exam Passer
· At least 2yrs Experience in Industry
Job Types : Full Time