regulatory pharmacist

2 days ago

Quezon City, National Capital Region, Philippines Powermeds Trading Full time $80,000 - $120,000 per year

Job Summary: The Regulatory Pharmacist is responsible for ensuring that all pharmaceutical products and company practices comply with relevant national regulations, including those set by the (FDA) Food and Drug Administration. This role involves preparing, reviewing, and submitting regulatory documents, ensuring licensing and product registration are maintained, and liaising with regulatory agencies.

Key Reponsibilities:

  1. Prepare, compile, and submit regulatory documents for FDA- registration, renewal and post-approval changes of drug products, cosmetics, food supplements, and medical devices.

  2. Monitor and ensure timely renewal of product registrations, license (LTO,CPR), and other regulatory permits.

  3. Coordinate with internal departments. for accurate documentation and regulatory compliance.

  4. Maintain records and documentation required by regulatory authorities.

  5. Represent the company in inspections and audits conducted by regulatory agencies.

  6. Evaluate products labels and promotional materials to ensure compliance with regulatory requirements.

  7. Ensure proper storage, handling and inventory control of regulated substances if applicable.

  8. Train employees on regulatory policies and compliance as needed.

Regulatory Compliance: ensure pharmacy operations strictly adhere to FDA requirements including renewal of eligibility documents for updated filing as drug distributor, along with industry standards. They communicate these requirements to their team, implementing training and compliance checks to maintain high legal and ethical standards.

  • With 2-3 years experience
  • Leadership Skills
  • Management Skills
  • Flexible
  • Fast Learner
  • Excellent attention to detail, documentation and organization skills.
  • Strong written and verbal communication skills.
  • Bachelor's Degree in Pharmacy, or any related field.
  • Preferably with license.

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