Regulatory Specialist Assistant
4 days ago
Key Responsibilities
Documentation & Submissions
- Assist in preparing and submitting regulatory documents (e.g., registration dossiers, technical files)
- Coordinate responses to regulatory agencies regarding product information or issues
Compliance Monitoring
- Help ensure products meet local and international regulatory standards
- Monitor changes in relevant legislation and update internal teams accordingly
Data Management
- Maintain regulatory databases and filing systems
- Track product complaints, adverse events, and regulatory correspondence
Cross-Functional Support
- Collaborate with R&D, Quality Assurance, and Marketing teams to ensure regulatory alignment
- Support internal audits and inspections by regulatory bodies
Labeling & Promotional Review
- Review product labeling and promotional materials for compliance
- Assist in implementing changes to regulatory policies and procedures
Qualifications
- Bachelor's degree in Life Sciences, Chemistry, Pharmacy, or related field
- 1–2 years of experience in regulatory affairs or compliance (preferred)
- Familiarity with FDA, EMA, or other regulatory bodies' guidelines
- Strong written and verbal communication skills
- Proficiency in Microsoft Office and regulatory software tools
Job Type: Full-time
Benefits:
- Life insurance
- Opportunities for promotion
- Paid training
Work Location: In person
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