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Regulatory Pharmacist

2 months ago

Manila, National Capital Region, Philippines Ambica International Corporation Full time
Regulatory Pharmacist Job Title: Regulatory Pharmacist Company: Ambica International Corporation

Job Description:

As a Regulatory Pharmacist, you will play a crucial role in ensuring that our company complies with applicable FDA and other regulatory-related government entities regulations on licenses, technical documents, and product registrations.

Key Responsibilities:

  • Regulatory Compliance: Ensure that all documents submitted to the FDA meet the required standards and guidelines.
  • Initial Applications: Prepare, evaluate, and submit initial applications for product registrations, including Biologicals Drug Applications.
  • Renewal and Revalidation: Renew and revalidate Principal Certificate of Product Registration and Certificate of Listing of Identical Product.
  • Equivalence Evidence Study: Communicate with suppliers, evaluate, and prepare submissions for Equivalence Evidence Study.
  • Variation/Amendment Applications: Prepare and submit variation/amendment applications for Certificate of Listing of Identical Product and Principal Certificate of Product Registration.
  • Follow-ups: Follow up on applications not yet evaluated by the FDA for timely release of approval.
  • Compliance: Ensure compliance with FDA requirements and deadlines.
  • Document Preparation: Prepare documents for PCPR and CLIDP Extensions, LTO applications, and LTO Renewals.
  • Client Queries: Respond to client queries regarding applications and other concerns.
  • Legal Documents: Evaluate legal documents as per FDA requirements and ensure all Legal Agreements are valid.
  • Regulatory Updates: Keep up-to-date with changes in regulatory legislation and guidelines and disseminate updates to the Regulatory Team.
  • Quality Standards: Ensure that quality standards are met and submissions meet strict deadlines.
  • Assistance: Assist with XD, Marketing, and BD requests.
  • GMP Clearance Applications: Prepare and submit GMP Clearance Applications and GMP Application Renewals.
  • LTO Inclusion: Submit LTO Inclusion applications.
  • Country-Specific Fees: Ensure that country-specific fees for applications are paid on time.
  • Quality Assurance: Perform Quality Assurance on all artwork and ensure labeling materials comply with FDA requirements.

Job Qualifications:

  • License/Registration: Must be a Licensed/Registered Pharmacist.
  • Experience: Preferably with years of work experience in the field of Regulatory.
  • Expertise: Has expertise in dossier preparation a plus.
  • Communication Skills: Good English communication skills and ability to type fast and accurately.
  • Information Handling: Able to handle and immerse lots of information about FDA applications.
  • Personal Qualities: Highly self-motivated, goal-oriented, and committed to pursuing a long-term career.
  • Work Ethic: Exceptionally well organized and strong work ethic.