Regulatory Officer

JOB DUTIES AND RESPONSIBILITIES

• Performs FDA liaison and assists FDA during audit or visit.
• Ensures GABC compliance by monitoring the FDA regulatory requirements and policies.
• Performs LTO application and renewal.
• Performs Product Notification application and renewal.
• Completes and files all documents related to FDA licenses and product records.
• Provides technical support to brands.

*Note: Other duties related to the responsibilities and output of the position but not included in this document may be assigned by the immediate superior.

QUALIFICATIONS:

EDUCATION REQUIRED

College graduate

EXPERIENCE

At least 2-3 years of experience in the related field.

Required Technical Skills:

1. PHILIPPINE FDA REGULATORY REQUIREMENTS AND COMPLIANCE
2. FDA PRODUCT REGISTRATION AND LICENSING
3. PREPARATION AND SUBMISSION OF REGULATORY DOCUMENTS
4. FDA ONLINE PORTALS AND REGULATORY SYSTEMS
5. PRODUCT, LABELING, AND CLAIMS COMPLIANCE REVIEW
6. REGULATORY MONITORING AND DEADLINE TRACKING
7. TECHNICAL DOCUMENT MANAGEMENT AND RECORD-KEEPING
8. REGULATORY RESEARCH AND INTERPRETATION

Required Behavioral Skills:

1. ATTENTION TO DETAIL
2. ACCOUNTABILITY AND OWNERSHIP
3. ORGANIZATION AND TIME MANAGEMENT
4. ANALYTICAL AND PROBLEM-SOLVING SKILLS
5.COMMUNICATION SKILLS
6.COORDINATION AND COLLABORATION
7.PROACTIVENESS
8.INTEGRITY AND PROFESSIONALISM