Regulatory Affairs Officer
abbvie
Full time
Regulatory Affairs Officer
getzhealthcare· Regulatory Affairs
About this role
The position is primarily responsible for handling Regulatory related matters and executing licensing, permits, and product registration activities of assigned Business Partner with the end goal of having internal processes that consistently comply with all regulatory standards. Ensure over all compliance and maintenance of company’s Pharmacovigilance system, render required assistance to Marketing Team in product planning and monitor the progress of activities based on timelines.
KEY RESPONSIBILITIES:
- Handles all the activities related to relevant Licenses to Operate (LTO), permits, certificates of registration from opening or initial, monitoring of validity, notification, renewal, filing of amendments, sales promo permit and withdrawal. Secures and provides the necessary documents from the FDA and other regulatory agencies as needed in a bid.
- Maintains complete and orderly file of documents both obsolete and current for the Department. Ensures availability of valid Regulatory documents including SOPs, CPRs, LTOs, GMPs and other related certificates.
- Establishes and maintains good working relationship with various regulatory agencies and organizations such as the Food and Drug Administration (FDA), Department of Health DOH), Philippine Drug Enforcement Agency (PDEA) and counterparts’ regulatory affairs of the Business Partner/s.
- Participates in activities organized by industry organizations and represent the company in pharmaceutical industry organizations as requested.
- Acts as focal person in handling Adverse Drug Reaction (ADR) Report and product complaint (safety related issues). Responsible in reporting the incidence to the Business Partner/s and to the local FDA.
- Performs local literature searches and keeps an organized filing system for PV audit.
- Performs other tasks that might be assigned from time to time
QUALIFICATIONS:
- Graduate of BS Pharmacy or any equivalent course. Must be a Registered Pharmacist.
- Minimum three (3) years of combined working experience in regulatory affairs preferably with exposure in food and cosmetics, pharmaceutical products, medical devices, and/or regulated drugs.
- Specific Knowledge: FDA Rules and Regulations and Business Understanding in Licensing and Product Registration Process, overall compliance of company, and Pharmacovigilance
Frequently Asked Questions
Is the salary disclosed for the Regulatory Affairs Officer position at getzhealthcare?
The salary for this Regulatory Affairs Officer role at getzhealthcare is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Regulatory Affairs Officer position at getzhealthcare located?
This Regulatory Affairs Officer role at getzhealthcare is based in Taguig City, Metro Manila, Philippines. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Regulatory Affairs Officer role at getzhealthcare full-time or part-time?
This is listed as a Full Time position. It is posted as a Regulatory Affairs Officer role in the Regulatory Affairs department at getzhealthcare.
Which team or department does the Regulatory Affairs Officer at getzhealthcare belong to?
This Regulatory Affairs Officer position is part of the Regulatory Affairs department at getzhealthcare. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Regulatory Affairs Officer position at getzhealthcare?
Click the "Apply Now" button on this page. You will be redirected to getzhealthcare's official application portal hosted on bamboohr where you can submit your application directly.
When was the Regulatory Affairs Officer job at getzhealthcare posted?
This Regulatory Affairs Officer position at getzhealthcare was posted on May 15, 2026. Apply as soon as possible — early applications are often reviewed first.
Regulatory Affairs Officer
getzhealthcare
You'll be redirected to getzhealthcare's official application page on bamboohr.