Regulatory Compliance Specialist
4 weeks ago
About the Role: Sesh Products US, Inc. is seeking a detail-oriented Regulatory Compliance Specialist to collaborate with our Operations, Customer Service, and Marketing teams on regulatory requirements around the Premarket Tobacco Application (PMTA) process.
The ideal candidate will have 1-2 years of experience in food, pharmaceutical, or tobacco products, with strong organizational skills and attention to detail. Familiarity with GMP, HACCP, QMS, and regulatory standards is required, with PMTA knowledge as a plus.
Key Responsibilities:
- PMTA Document Management: Manage and oversee controlled document updates, specifically around PMTA submissions, policies, and regulatory instructions.
- Document Lifecycle: Coordinate document preparation, routing, review, approval, distribution, and archival in line with FDA PMTA guidelines.
- Change Management: Process change orders for PMTA-related documents and regulatory requirements.
- Organize Regulatory Files: Ensure accurate filing systems for PMTA and other regulatory documents.
- Data Compilation: Prepare data for QA meetings, management reviews, and supplier reviews.
- Audit Preparation: Support internal and external audits, especially in relation to PMTA requirements and compliance.
- Non-Conformance & Complaints: Manage non-conformance documentation and assist in resolving regulatory-related customer complaints.
- Training Coordination: Train staff on PMTA documentation protocols and maintain up-to-date training records.
Salary Range: $60,000 - $80,000 per year
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Regulatory Compliance Specialist
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