Regulatory Affairs Associate

4 weeks ago

Metro Manila Philippines &you Full time

Overview

Regulatory Affairs Associate role focusing on FDA submissions in the Philippines for a telehealth platform addressing health issues in Southeast Asia. You’ll bridge our teams and the FDA to ensure submissions, licenses, and product approvals are accurate, timely, and compliant. This role requires attention to detail, collaboration with cross-functional teams, and the ability to thrive in a fast-moving, mission-driven company.

Location: Our head office is in Taguig City, BGC. We offer flexi-time to support work-life balance and on-site collaboration at the BGC office.

Responsibilities
  • Prepare and submit FDA applications through new product registrations, CPR (Certificate of Product Registration), LTO (License to Operate), variations, renewals, and amendments.
  • Track submission progress and proactively follow up with FDA officers to ensure timely approvals.
  • Maintain up-to-date regulatory databases (e.g. FDA eServices, internal dashboards) for licenses, certificates, and renewal timelines.
  • Review product labeling and promotional materials for FDA compliance (claims, warnings, required text).
  • Coordinate FDA inspections, audits, and post-approval obligations, including annual reporting and pharmacovigilance (if applicable).
  • Respond to deficiency letters or queries from FDA within prescribed timelines, with strong technical and regulatory justification.
  • Keep the team updated on FDA circulars, advisories, and new regulatory guidelines — and recommend compliance strategies.
  • Work cross-functionally with R&D, Quality, Marketing, and Supply Chain to gather technical documentation for FDA submissions.
Qualifications
  • Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related life science.
  • At least 1–3 years of regulatory affairs experience focused on FDA submissions (CPR, LTO, renewals, etc.).
  • Knowledge of FDA Philippines regulations, processes, and eServices portal.
  • Excellent communication skills in English and Filipino for dealing with FDA officers and internal teams.
  • Strong organizational skills and ability to manage multiple regulatory projects at once.
  • Licensed Pharmacist (PRC) — highly preferred for FDA-facing roles.
  • Experience handling FDA requirements for pharmaceuticals, cosmetics, food supplements, or medical devices.
  • Familiarity with ASEAN regulatory frameworks and guidelines.
  • Exposure to GMP, Quality Systems, and product lifecycle management.
  • Willingness to work on-site daily at our BGC office and collaborate in person with the team.
How to apply

If you’ve got the spark we’re looking for, apply directly through this post or send an email to

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