Regulatory Affairs Executive
1 week ago
Makati, National Capital Region, Philippines
Regulatory Affairs ExecutiveAllegens Healthcare Makati, National Capital Region, Philippines
- Prepare, check, compile and submit the company's product registration dossiers including drugs, functional foods, medical devices, cosmetics, etc. (including new registration dossiers/ renewal dossiers/ supplementary dossiers/ change dossiers).
- Responsible for ensuring that the dossiers are correct and accurate according to the regulations of the Pharmaceutical Law and current legal regulations of the FDA.
- Work with manufacturers to provide documents and dossiers related to registration.
- Ensure the submission and approval of all delivered drugs within the optimal time schedule.
- Handle issues related to the Company's drug registration dossiers.
- Make periodic/ad hoc work reports as required by management.
- Manage documentation and track regulatory submissions and approvals.
- Collect and store complete and accurate documents, dossiers and dossiers.
- Coordinate with internal departments to ensure compliance with regulatory requirements.
- Update knowledge and requirements according to FDA regulations
- Support product labeling, packaging, and promotional materials compliance.
- Build good relationships and company image with FDA.
- Graduated from university or college
- Experience 2-3 years as regulatory affairs for drug registration
- Fluent in English
- Professional attitude and appearance
- Solid written and verbal communication skills
- Ability to be resourceful and proactive when issues arise
- Excellent organizational skills
- Multitasking and time-management skills, with the ability to prioritize tasks
Salary Range: Negotiable
Working Time: 08:00 – 17:00 (Mon – Fri, alternate Saturday), lunch time: 12:00 – 13:00
Seniority levelMid-Senior level
Employment typeFull-time
Job functionBusiness Development and Sales
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