Regulatory Compliance Supervisor
2 weeks ago
The Regulatory Compliance Supervisor will play a crucial role in ensuring adherence to regulatory standards within the organization. This position involves collaborating closely with the Manager to facilitate cGMP, Environmental, and Regulatory audits, as well as assisting in the creation and organization of essential product documentation, including product master files (dossiers) and drug master files (DMF).
Key Responsibilities
1. **Documentation Management**: Generate and review Certificates of Compliance (CoCs), Certificates of Analysis (CoAs), Certificates of Materials (CoMs), and other regulatory documents as required for both local and international submissions.
2. **Regulatory Statements**: Prepare various Raw Material Regulatory statements, including but not limited to Origin Statements, Clean Lists, and compliance statements for global and regional regulations.
3. **Vendor Communication**: Manage and maintain effective communication with vendors and suppliers to obtain necessary raw material documentation and follow up on requests.
4. **Compliance Review**: Conduct thorough reviews of formulas, ingredients, and associated documentation to ensure compliance with regulatory requirements and proposed submissions.
5. **Regulatory Audits**: Coordinate investigations related to audit findings and manage correspondence with regulatory agencies regarding product registrations and facility compliance.
6. **SOP Adherence**: Ensure strict compliance with all Standard Operating Procedures (SOPs) and regulatory requirements from various agencies, including FDA, EPA, and Health Canada.
7. **Training and Updates**: Assist in periodic regulatory reviews, updates, and training sessions to keep the team informed of the latest regulatory changes.
Qualifications
- A minimum of a Bachelor’s degree in Life Sciences, Engineering, or a related field.
- At least three years of relevant experience in drug, cosmetic, or medical device regulatory environments.
- Familiarity with FDA regulations under 21CFR 210, 211, and 820 is essential.
- Previous experience in regulatory affairs, inspections, or auditing is advantageous.
- Strong data analysis skills and proficiency in computer applications are preferred.
Benefits
- Comprehensive Medical, Dental, and Vision Insurance
- Life Insurance Coverage
- 401k Matching Program
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