Regulatory Affairs Officer

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