Regulatory Pharmacist

23 hours ago

Mandaluyong City, National Capital Region, Philippines I.E. Medica Inc. Full time

The Regulatory Pharmacist is responsible for the review and evaluation of dossiers for identified priority products, ensuring compliance with the Philippine FDA's requirements and submission deadlines. The role involves coordinating with suppliers, preparing artwork, and supporting regulatory officers in FDA submissions and database management.

Key Responsibilities:

Dossier Review and Evaluation:

  • Conduct thorough reviews of dossiers for priority products.
  • Evaluate the completeness and accuracy of dossier content.
  • Take into account the exchange of communications between the Regulatory Officer in-charge and the supplier.
  • Identify and address any discrepancies or missing information.

Artwork Preparation:

  • Review artwork for dossiers as per Philippine FDA requirements.
  • Ensure artwork meets all regulatory standards and guidelines.

Supplier Coordination:

  • Liaise with suppliers to request additional information or clarifications.
  • Facilitate effective communication to resolve any issues related to dossier content.

Initial Registration, Monitored Release Registration, Variation Applications, and Notifications:

  • Review and evaluate dossiers provided by suppliers/clients for various regulatory applications.
  • Ensure all required documentation is complete and compliant.
  • Prepare artwork as needed for these applications.

Support to Operations:

  • Assist colleagues in preparing and submitting dossiers to the Philippine FDA.
  • Ensure all submissions are accurate, complete, and timely.
  • Update the database with relevant information related to dossier submissions and communications.
  • Maintain an accurate and up-to-date database of all regulatory activities.

Qualifications:

  • Registered Pharmacist
  • Minimum of 1-2 years of experience in regulatory affairs, preferably in the pharmaceutical industry.
  • Strong understanding of Philippine FDA regulations and submission processes.
  • Excellent attention to detail and analytical skills.
  • Proficient in Microsoft Office or Google Workspace applications and database management.
  • Excellent communication and coordination skills.

Why Choose Us?

Professional Development: We offer extensive training and mentoring programs.

Supportive Teamwork: Collaborate with seasoned experts and vibrant teams.

Career Progression: Enjoy defined career trajectories and chances for promotion.

Rewarding Compensation: Receive a competitive salary and benefits package (HMO + 2 free, Life & Accident Insurance, Leave Conversion, Travel Incentive, Performance Based Bonus up to x3 and Ayala Benefits) .

Job Types: Full-time, Permanent, Fresh graduate

Pay: Php22, Php25,000.00 per month

Benefits:

  • Additional leave
  • Company Christmas gift
  • Company events
  • Employee discount
  • Flexible schedule
  • Flextime
  • Health insurance
  • Opportunities for promotion
  • Paid training
  • Pay raise
  • Promotion to permanent employee
  • Transportation service provided

Work Location: In person

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