Regulatory Affairs Associate

Job description:

Main Function

A Regulatory Affairs Associate is responsible for managing, coordinating, and documenting internal regulatory processes, which may include inspections, internal audits, license renewals, registrations, and several other processes under government regulations and ensure compliance of the company to Quality Safe Health and Environment policies and procedures.

Duties and Responsibilities:

• Initial registration and life cycle management of product licenses. ∙
• Maintenance of License to Operate as Medical Device Importer/Distributor.
• Design and implementation of regulatory strategies to meet objectives and timelines set for licensing, registration of products and other related regulatory matters.
• Conduct regulatory alignment with foreign suppliers for any change in FDA regulation and updates.
• Acts as the main focal point for Philippines for any regulatory queries from suppliers and provide regulatory support as appropriate
• Attend to inspector/s during FDA audits.
• Ensure proper management and safekeeping of records in compliance with FDA regulations.
• Clearance from other non-FDA regulating bodies (OMB, NTC, etc.)
• Copy review of promotional materials.
• Monitors changes in regulatory environment and participates in relevant industry meetings in order to help shape draft regulations in the Philippines.
• Takes action accordingly to minimize any risk that the company may be subjected to.

• Prepares and updates Standard Operating Procedures (SOP), Work Instructions (WI) and policies on an as-need basis.
• Product complaints handling and reporting in accordance to supplier SOP.
• Handles Field Actions in accordance to supplier process.
• Point person during supplier audits.

Job Requirements:

• Candidate must possess at least Bachelor’s/ College Degree in Pharmacy.
• Must be a registered Pharmacist.
• Newly graduate is welcome to apply.

Benefits:

• Flexible schedule
• HMO
• Life Insurance
• Hybrid