Regulatory Affairs Specialist Med Device Cosmetics OTC
Talentmate
Philippines
10th January 2026
2601-2544-727
Job Description
- A leading healthcare solutions provider in Asia.
- Recognized for its regulatory excellence, and strong compliance.
A business supporting pharmaceutical, medical device, and consumer healthcare companies through regulatory affairs, distribution, commercialization, and patient access services.
Job Description
Key Responsibilities
- Ensure regulatory compliance in the distribution of pharmaceutical and healthcare products
- Manage and monitor validity of Certificates of Product Registration (CPRs) and other regulatory authorizations
- Represent in engagements with Regulatory Health Authorities, including the Philippine FDA
- Execute key regulatory actions to support business and commercial requirements
- Ensure adherence to current and emerging regulations, cascading updates to relevant stakeholders
- Prepare, review, and submit regulatory filings (initial, renewal, amendments, GLE, clinical submissions)
- Communicate and coordinate with clients regarding regulatory requirements and timelines
- Support Medical Affairs in clinical trial submissions, reporting, and documentation
- Support Pharmacovigilance activities, including safety reporting to FDA
- Implement Corrective and Preventive Actions (CAPA) as required
- Review and approve product labels, claims, packaging artworks, inserts, and stickers
- Monitor compliance of all packaging materials against approved regulatory standards
- Review and approve promotional materials, programs, advertisements, and direct-to-consumer campaigns
- Provide regulatory support for hospital formulary listings and bidding processes
- Prepare regulatory proposals and costing for new business opportunities
- Engage with regional teams on in-licensed brand regulatory requirements
- Coordinate investigations related to product complaints with clients
- Provide product release disposition for products when required
- Approve repackaging work instructions based on Packaging Materials Reference Standards
Qualifications
- Bachelors Degree in Pharmacy
- Licensed Pharmacist (mandatory)
- 1-3 years of Regulatory Affairs experience
- Growth mindset
- Driven and proactive (go-getter)
- Highly committed and dependable
- Willing to be based in Sucat
- Willing to work fully onsite
- Competitive annual salary
- Comprehensive health insurance (HMO).
- Opportunity to work with a leading healthcare company in Asia
- High-impact role supporting market access, clinical, pharmacovigilance, and commercial teams
- Stable, long-term career path with learning and leadership opportunities
Contact: Eds Manuel
Quote job ref: JN-012026-6917720
Job Details
| Role Level: | Entry-Level | Work Type: | Full-Time |
|---|---|---|---|
| Country: | Philippines | City: | Metro Manila |
| Company Website: | https://redirect.michaelpage.com/mp-home | Job Function: | Science |
| Company Industry/ Sector: |
Medical Equipment Manufacturing Hospitals And Health Care And Pharmaceutical Manufacturing | ||
What We Offer
About the Company
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