Regulatory Affairs Specialist
Specialty Lifestyle Concepts, Inc. Makati Full-time
Primary Function
- Supports the preparation and submission of regulatory documents for plant and importation, ensuring compliance with government agencies.
- Liaisons with regulatory authorities to ensure timely approvals and maintain regulatory compliance of FDA, DA (NMIS, BAI, BPI, SRA), DTI, etc.
- Monitor, prepare, compile, and submit plant and product registrations, renewals and variations in accordance with regulatory requirements.
- To do actual liaison relevant to the process documents.
- Monitor updates in regulatory requirements and guidelines and assist in implementing necessary changes.
- Review labeling, packaging, and promotional materials to ensure regulatory compliance.
- Serve as a contact for regulatory authorities, ensure effective communication and address regulatory concerns.
- Coordinate with suppliers for the submission of required documents.
- Coordinates with the third-party laboratories and internal results.
- Collaborate with internal teams (QA/RND,Marketing, Warehouse, Finance) to gather required documents and data for regulatory purposes.
- Handle other necessary regulatory transactions as needed by the company.
Pasay, 2 km from Makati
The Regulatory Affairs Manager is responsible for ensuring that the company complies with regulations related to quality and Food and Drug Administration (FDA) standards.
SPECIFIC DUTIES & RESPONSIBILITIES
1. Initial and renewal registration of all...
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