Regulatory Affairs Associate
2 days ago
WHO we are:
A telehealth platform focusing on transformative, stigmatized health issues. Our goal is to address Southeast Asia's most overlooked and misunderstood health concerns.
WHERE and HOW you can work:
Our head office is located in the heart of Taguig City, at BGC, a vibrant business and lifestyle hub. We offer our employees the benefit of flexi-time, allowing them to enjoy that one last bite of breakfast, savor an extra cup of coffee, or fit in a quick visit to the gym, empowering them to start their day on their terms.
WHAT this role means for you:
We're looking for a Regulatory Affairs Associate (FDA) to help us bring innovative, safe, and compliant products to market in the Philippines. You'll be the bridge between our teams and the FDA, ensuring that all our submissions, licenses, and product approvals are accurate, timely, and successful.
This role is perfect if you're detail-oriented, love working with cross-functional teams, and thrive in a fast-moving, mission-driven company.
You're a match if you:
- 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.
Profile Wishlist:
- 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.
If you've got the spark we're looking for, apply directly through this post or send an email to
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