Regulatory Pharmacist

Sytengco Group of Companies; Quezon City; On-site; PHP 279,000 - 390,600; Full time

Job summary

A pharmaceutical company is seeking a qualified Regulatory Pharmacist to ensure compliance with government regulations for pharmaceutical products. Responsibilities include handling FDA applications, representing the company during inspections, and maintaining organized documentation. Candidates should have a Bachelor of Science in Pharmacy and be a registered pharmacist. This role involves both office and fieldwork, and the ideal candidate will be confident, cooperative, and able to work under pressure.

Qualifications

• A Registered Pharmacist with valid PRC License ID is required.
• Bachelor of Science in Pharmacy is essential.
• Experience in regulatory affairs is a plus.

Responsibilities

• Function as the Company Pharmacist of SBS Philippines Corporation.
• Handle overall legal requirements for FDA applications.
• Ensure licenses and permits are updated for inspections.
• Represent the company during FDA inspections.
• Monitor and follow-up on pending applications regularly.
• Maintain organized files and records for management.

Education

Bachelor of Science in Pharmacy

Registered Pharmacist with valid PRC License ID

Tools

MS Office

Job description

Regulatory Pharmacist are responsible and qualified individuals to ensure that the company is compliant in all regulatory requirements of the government in relation to the importation, distribution and sale of the chemical, pharmaceutical, and medical products of the company in an efficient and timely manner. The purpose of this job is to provide assistance regarding documentation and monitoring regulation of products in different government agencies.

Responsibilities

1. To function as the Company Pharmacist of SBS Philippines Corporation.
2. Handles the overall legal requirements of the company’s application to FDA’s CDRR, CFRR, and CDRRHR under SBS Philippines Corporation.
3. Ensures that LTOs and CPRs and other documents needed for FDA application and inspection are updated and valid.
4. Represents the Company during FDA inspections.
5. Ensures that all applications are properly submitted until completely processed.
6. Monitors and follow-ups the pending applications regularly/
7. Prepares, evaluates, and submits documents for deficiencies, amendments, and other compliance.
8. Handles licenses and permit registrations of the SBS Philippines Corporation in Bureau of Animal Industry.
9. Assists the Regulatory Head on other Government Registrations under SBS Philippines Corporation.
10. Informs the Regulatory Head of FDA updates.
11. Updates the master list of products and filing of CPRs.
12. Maintains an organized file and records for management of the authenticated and other important documents.
13. Responsible for other relevant tasks that may be assigned by the Regulatory Head and/ or the Management.

Education

• Bachelor of Science in Pharmacy
• Registered Pharmacist with valid PRC License ID

Specialized Skills

• Regulatory Affairs
• Computer Literate
• Interpersonal Communication Skills

Experience

• With or Without experience

Knowledge

• Regulatory Policies and Procedures
• Chemical and Pharmacological Properties

Soft Skills

• Follow rules and regulations
• Interpersonal communication skills
• Logical Thinking
• Teamwork
• Multi-tasking

Technical Skills

• Knowledgeable in MS Office

Attitude

• Act Professionally
• Confident
• Cooperative
• Persistent
• Flexible

Working Condition

• Willing to do office and field works
• Ability to work under pressure

Physical Requirements

• Physically strong and fit to work