Regulatory Compliance Associate

3 days ago

Batangas, Calabarzon, Philippines D & L Industries Full time $104,000 - $130,878 per year
Key Responsibilities
  • Regulatory Compliance: Represent the company in complying with government regulating bodies' requirements for products and facilities (excluding local permits).
  • Documentation & Registration: Check necessary documents and create Product Information Files (PIF) for FDA product registration.
  • Product Development Understanding: Understand all aspects of product development, including research, clinical trials/tests, manufacturing practices, regulations, and approval processes.
  • Project Team Participation: Participate with project teams on regulatory requirements for export, labeling, or clinical study compliance.
  • Guidance & Interpretation: Provide and explain regulations, policies, or procedures, and identify/interpret regulatory guidelines.
  • Law Evaluation: Evaluate applicable laws and regulations to determine their impact on company activities.
  • Documentation Coordination: Coordinate regulatory documentation activities.
Qualifications
  • Education: Licensed Pharmacist or Chemical Engineer.
  • Experience: Relevant years of related work experience.
  • Skills: Proficient in oral and written communication; Computer literate.

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