Regulatory Compliance Specialist
1 month ago
Regulatory Compliance Specialist - SBS Philippines Corporation
About the RoleThe Regulatory Pharmacist will play a vital role in ensuring that SBS Philippines Corporation is compliant with all regulatory requirements of the government. This involves assisting with documentation and monitoring regulation of products in different government agencies.
Key Responsibilities- To function as the Company Pharmacist of SBS Philippines Corporation.
- Handle the overall legal requirements of the company's application to FDA's CDRR, CFRR, and CDRRHR under SBS Philippines Corporation.
- Ensure that LTOs and CPRs and other documents needed for FDA application and inspection are updated and valid.
- Represent the Company during FDA inspections.
- Ensure that all applications are properly submitted until completely processed.
- Monitor and follow up on pending applications regularly.
- Prepare, evaluate, and submit documents for deficiencies, amendments, and other compliance.
- Handle licenses and permit registrations of the SBS Philippines Corporation in Bureau of Animal Industry.
- Assist the Regulatory Head on other Government Registrations under SBS Philippines Corporation.
- Inform the Regulatory Head of FDA updates.
- Update the master list of products and filing of CPRs.
- Maintain an organized file and records for management of authenticated and other important documents.
We are looking for a qualified individual with a Bachelor of Science in Pharmacy and a valid PRC License ID. The ideal candidate should have experience in Regulatory Affairs, be computer literate, and possess excellent interpersonal communication skills. Knowledge of regulatory policies and procedures, chemical and pharmacological properties, and soft skills such as logical thinking, teamwork, and multitasking are also essential.
Working ConditionsThe successful candidate will be willing to perform office and field work and be able to work under pressure. They should be physically strong and fit to work.
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