Regulatory Affairs Pharmacist

2 weeks ago

Quezon City, National Capital Region, Philippines NEW SMART FORMULAE TRADING CORP. Full time

Position available for both Full-time, or Part-time

Work Set-Up: Hybrid (report to office twice a week)

As a Regulatory Affairs Pharmacist under New Smart Formulae Trading Corporation, your key responsibilities include:

Regulatory Compliance

  • Be the point of contact for regulatory agencies to address questions, deficiencies, and required clarifications.
  • Ensure compliance with FDA regulations for drugs, food, and other relevant product categories.
  • Prepare and coordinate during FDA regulatory inspections and internal audits.
  • Assist in responding to regulatory concerns and providing necessary documentation.
  • Monitor, interpret, and implement changes in accordance to the latest regulatory guidelines and best practices that may impact product availability or marketability.
  • Maintain alignment with industry standards for product registration, and labeling compliance.
  • Provide support during emergency regulatory updates (e. g. product holds).

Documentation & Submissions

  • Prepare, compile, and submit regulatory documents such as FDA and DOH applications, CPR, GMP and GDP related submissions, and product notifications.
  • Maintain updated, accurate, and organized records of all regulatory files, correspondences, and submission histories.
  • Track all regulatory timelines to ensure timely approvals.

Qualifications:

  • Bachelor's degree in Pharmacy
  • Active PRC Pharmacist license
  • 1 - 3 years experience in Regulatory Affairs, preferably in pharmaceuticals, food, or medical devices
  • Applicants with no experience but strong scientific and documentation background may be considered.

Skills:

  • Strong understanding of FDA guidelines, Human Drugs regulations, Food regulations, and international standards.
  • Excellent organizational skills and high attention to detail.
  • Strong analytical thinking and problem-solving ability.
  • Proficiency in MS Office (Word, Excel, PowerPoint) and familiarity with regulatory submission tools (e.g., eCTD).
  • Good verbal and written communication skills in Filipino and English.
  • Able to work independently and with minimal supervision.

Job Types: Full-time, Part-time

Pay: Php11, Php20,000.00 per month

Expected hours: 24 – 40 per week

Benefits:

  • Company events
  • Health insurance
  • Life insurance
  • Promotion to permanent employee
  • Work from home

Application Question(s):

  • Are you looking to apply as a full-time or part-time employee?

Experience:

  • regulatory affairs: 1 year (Preferred)

License/Certification:

  • Pharmacist license (Required)

Work Location: Hybrid remote in Quezon City

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