Regulatory Affairs Assistant

I. Job Summary

This role provides vital support in ensuring regulatory compliance with local regulations, particularly those of the Food and Drug Administration (FDA). The position involves assisting with the preparation and submission of regulatory documents, coordinating with internal teams and external partners, and supporting various regulatory activities to help bring products to market.

Key Responsibilities:

• Assist in preparing, reviewing, and submitting regulatory documents and technical files for product registrations and renewals with the FDA.
• Coordinate with principals/suppliers to collect and organize necessary documentation for regulatory submissions.
• Maintain accurate and up-to-date records of all regulatory transactions and correspondence.
• Support the team in monitoring the status of submissions and ensuring timely follow-ups with regulatory agencies.
• Assist in preparing summary reports, data tabulations, and filing of technical information.
• Ensure proper documentation and filing in accordance with internal procedures and regulatory standards.
• Handle sensitive and proprietary information with confidentiality and professionalism.
• Stay updated on regulatory requirements and industry best practices

II. Job Requirements
Education: Bachelor’s degree in Pharmacy, Biology, Chemistry, or a related life sciences field
Experience: No prior experience required; internship or academic exposure to regulatory concepts is a plus

Skills:
**-**Strong attention to detail and organizational skills

• Good communication skills, both written and verbal.
• Ability to work collaboratively and independently in a team-oriented
  environment.
• Proficiency in Microsoft Office applications (Word, Excel, Outlook).
• Willingness to learn and grow within the regulatory affairs field

Job Type: Full-time

Pay: Php19,000.00 - Php20,000.00 per month

Benefits:

• Health insurance
• Opportunities for promotion

Work Location: In person