Pharmacy

Regulatory Affairs Specialist

JOB SUMMARY

As a Regulatory Affairs Specialist, you will be responsible for preparing, reviewing, and submitting regulatory documents to ensure compliance with FDA, DOH, and other health authorities. You will collaborate with cross-functional teams to support product registrations, renewals, and variations, while staying updated on evolving regulations and policies.

Principal accountabilities & Responsibilities

Prepare and submit product registration dossiers, renewals, amendments, and variations in compliance with regulatory authority requirements (e.g., FDA, DOH)

Liaise with government regulatory agencies to ensure timely approval and registration of products

Maintain regulatory files and documentation in accordance with company policies and regulatory requirements

Monitor changes in relevant laws and regulations and assess their impact on company operations and product portfolios

Provide regulatory input during product development, packaging, and labeling reviews

Support internal audits and inspections related to regulatory compliance

Ensure that all marketed products remain compliant with applicable laws and regulations throughout their lifecycle

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qualification Requirements

Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related life sciences field

Minimum 2 years of experience in a regulatory affairs role within the pharmaceutical, medical device, or healthcare industry

Knowledge of local (e.g., Philippines FDA, DOH) and international regulatory requirements

Strong attention to detail and organizational skills

Excellent written and verbal communication skills

Ability to manage multiple projects and deadlines

Proficiency in MS Office applications (Word, Excel, PowerPoint)

Regulatory certification is a plus (e.g., RAC)

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Regulatory Affairs Specialist

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