Regulatory Affairs Pharmacist

1 week ago


Paranaque City, Calabarzon, Philippines IFace Inc. Full time

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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