Regulatory Affairs Pharmacist
3 days ago
Job Responsibilities:
- Manage end-to-end Philippine FDA processes, including:
– LTO application and renewal
– Product registration (initial, renewal, variation, post-approval changes)
– CPR submissions and maintenance - Ensure all regulatory submissions are accurate, complete, and submitted within FDA timelines.
- Monitor updates, circulars, and new guidelines issued by the Philippine FDA and implement required changes internally.
- Coordinate with FDA evaluators, inspectors, and government agencies to facilitate inspections and compliance assessments.
- Lead regulatory strategies for new product launches, reformulations, and product lifecycle management.
- Maintain and organize regulatory documentation, records, and compliance logs.
- Conduct product tests for all finished goods distributed and imported by the company.
- Coordinate and monitor the destruction and disposal of rejected, damaged, or expired finished product and components.
- Provide regulatory guidance to internal teams such as QA, QC, R&D, Production, and Sales & Marketing.
Qualifications:
- Licensed Registered Pharmacist (required).
- Minimum of 4 years experience in regulatory affairs within the pharmaceutical, health and beauty industry.
- Demonstrated experience specifically with Philippine FDA regulatory processes and compliance requirements is essential.
- Strong knowledge of Philippine FDA laws, rules, and regulations.
- Excellent communication, technical writing, and document control skills.
- Ability to manage multiple submissions and strict deadlines.
- Detail-oriented, proactive, and capable of leading regulatory improvement initiatives.
- Willing to be assigned on site at Sta. Ana Drive, Sun Valley Parañaque City.
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