Regulatory Specialist
3 weeks ago
Job description
Regulatory Specialist
- Food Registrations (FDA) – review and preparation of documents and actual sample for submission
- Initial Applications
- Renewal Applications
- Reapplications (submissions with compliance)
- 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)
- Attend meetings/seminars within and outside the organization as advised by the immediate superior
- 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
- Familiarity with FDA Guidelines
- BS PHARMACY Graduate
- Pharmacist's Licensure Exam Passer
- At least 2 years Experience in Industry
Job Types: Full Time
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