Regulatory Affairs Associate

2 weeks ago

Pasig, National Capital Region, Philippines Pharmastar International Trading Corporation Full time ₱1,200,000 - ₱2,400,000 per year

About the Role

This position involves managing regulatory submissions, maintaining compliance documentation, and liaising with regulatory agencies to facilitate product approvals. The ideal candidate will possess strong knowledge of regulatory affairs, attention to detail, and the ability to navigate complex regulations in the pharmaceutical, biotechnology, or medical device industries. This is an excellent opportunity for someone who thrives in a dynamic, fast-paced environment and is eager to contribute to product development and market access.

Responsibilities

  • Perform various functions pertinent to preparation of regulatory documents and documents for product registration.
  • Maintain current knowledge of relevant regulations, including proposed and final rules to ensure compliance with regulatory standards and guidelines
  • Represent the company for FDA transactions and registration of products. (CDRRHR and CCRR)
  • Perform liaison activities at the Food and Drug Administration, IPO and other agencies.

Qualifications

  • Graduate of Bachelor of Science in Pharmacy/ Licensed Pharmacist
  • In-depth knowledge of regulatory guidelines and standards in the industry
  • At least 1-2 years of working experience in the related field is required for this position
  • Excellent written and verbal communication skills
  • Detail-oriented with strong organizational and analytical skills

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