Regulatory Officer
Full-time
Sytengco Group of Companies
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.
- To function as the Company Pharmacist of SBS Philippines Corporation.
- Handles the overall legal requirements of the company’s application to FDA’s CDRR, CFRR, and CDRRHR under SBS Philippines Corporation..
- Ensures that LTOs and CPRs and other documents needed for FDA application and inspection are updated and valid.
- Represents the Company during FDA inspections.
- Ensures that all applications are properly submitted until completely processed.
- Monitors and follow-ups the pending applications regularly/
- Prepares, evaluates, and submits documents for deficiencies, amendments, and other compliance.
- Handles licenses and permit registrations of the SBS Philippines Corporation in Bureau of Animal Industry.
- Assists the Regulatory Head on other Government Registrations under SBS Philippines Corporation.
- Informs the Regulatory Head of FDA updates.
- Updates the master list of products and filing of CPRs.
- Maintains an organized file and records for management of the authenticated and other important documents.
- Responsible for other relevant tasks that may be assigned by the Regulatory Head and/ or the Management.
Education
- Bachelor of Science in Pharmacy or any Related field
- Registered or Unregistered
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
Vacancy posted a month ago
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