
Regulatory Compliance Officer
4 days ago
Company Overview
TOPLC Biomedical, Inc. is a company that specializes in manufacturing and importation of food supplements, cosmetics and medical devices under our clients' house brands. With factories located in Taiwan, TOPLC is proud to provide high-quality, safe and unique products to the market.
Benefits:
Bonuses:
1. Signing bonus worth Php 50,000 to 100,000
2. Annual Bonus worth 1-2 months salary
3. Service Bonus
4. Attendance Bonus
5. Incentive Leaves and Long Holidays
6. Health Maintenance Organization (HMO-Employee with dependents included)
7. Opportunity to travel to Taiwan
Your responsibilities will include:
· Prepares & submits documents to Philippine Food and Drug Administration (FDA) such as License to Operate (LTO) & drug product - ACTD document for Initial registration, Site Registration/GMP Clearance applications, BA/BE study report, renewal of CPR, including variations and compliance of existing products.
· Must know or have an experience applying Initial and renewal application for drug products.
· Monitors the status of applications with the FDA.
· Creates and reviews packaging layouts in line with existing standards set by FDA.
· Handles company inspection and audit relevant to third party and government agencies.
· Handles applications with Intellectual Property Office (IPO) for trademarks and other functions of the agency.
· Directly reports to Regulatory Manager.
To be successful in this role, you will need to have:
· Bachelor's Degree in Pharmacy or any related courses in Medical Field.
· At least 2 years of working experience as Regulatory Compliance Officer.
· Detail oriented and attention to accuracy.
· Excellent communication and interpersonal skills.
Why join us?
· Multinational Company based in Taiwan and Philippines.
· Trending Healthcare Industry.
· Top Class Training.
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