Registered Pharmacist - Regulatory
28000 - 30000 PhpPharma-surrey International, Inc.
Fresh Grads are welcome to apply!
Salary: ₱28,000–₱30,000 per month
HMO upon regularization
Government-mandated contributions
13th-month pay
CPR incentives
Other performance-based incentives
Regular salary increases based on performance and company policy
Key Responsibilities:
· Product Registration: Prepare, review, and submit product registration dossiers and applications for Certificates of Product Registration (CPRs), including renewals, variations, and other post-approval changes.
· Batch Notification, Lot Release, and Local Assay Testing: Review, prepare, and submit Batch Notification (BN) applications and Lot Release Certificates (LRCs). Coordinate local assay testing with accredited laboratories, including CEDRES and PGH, and monitor the status of testing requests and results.
· CPR and GMP Monitoring: Monitor the validity and renewal deadlines of CPRs, Good Manufacturing Practice (GMP) certificates, and other relevant regulatory documents to ensure they remain current and compliant with applicable requirements.
· Regulatory Compliance: Ensure that company operations, pharmaceutical products, and storage facilities comply with applicable laws, regulations, and requirements of relevant government agencies, including the Philippine FDA, Philippine Drug Enforcement Agency (PDEA), and Dangerous Drugs Board (DDB).
· Product Labeling and Artwork Review: Review product packaging, labels, package inserts, and related product information to ensure scientific accuracy and compliance with applicable Philippine FDA labeling requirements.
· Regulatory Intelligence: Monitor changes in regulatory policies, administrative orders, guidelines, and other government issuances, and communicate relevant updates and compliance requirements to internal teams.
· Audit and Inspection Support: Coordinate and assist in preparation for regulatory inspections and internal quality audits, including the compilation of required documents, review of compliance records, and follow-up on findings and corrective actions.
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