Regulatory Compliance Officer

5 days ago

Pasig, National Capital Region, Philippines TOPLC Biomedical, Inc. Full time ₱800,000 - ₱1,200,000 per year

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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