Regulatory Affairs Pharmacist

1 week ago

Pasay, National Capital Region, Philippines Ambica International Corporation Full time ₱50,000 - ₱150,000 per year
  • Responsible for ensuring the correctness and compliance of the documents per FDA Guidelines for the Initial Applications and Biologicals Drug Applications upon submission to the FDA to merit approval and secure a Certificate of Product Registration.
  • Ensures that approval and Certificate of Product Registration will be given for the Initial Registration of Food Initials, Medical Device Initials, and Cosmetic Notifications.
  • Responsible for renewal and revalidation of Principal Certificate of Product Registration and Certificate of Listing of Identical Product and ensure that the documents are overflowing with quality to secure the approval from FDA.
  • Communicates Equivalence Evidence Study with the supplier, evaluates, and prepares for submission. Makes sure that the Bioequivalence Study Report meets the Criteria of ASEAN Guidelines, and Biowaiver Study/Comparative Dissolution Profile meets the WHO Guidelines.
  • Responsible for variation/amendment applications of Certificate of Listing of Identical Product and Principal Certificate of Product Registration.
  • Responsible for having follow-ups for the applications that were not yet evaluated by the FDA for timely release of approval from the FDA.
  • Able to submit compliance on or before the deadline as prescribed by FDA.
  • Prepares documents for PCPR and CLIDP Extensions.
  • Prepares documents for regulatory purposes/FDA concerns such as LTO application and LTO Renewal.
  • Responds to client/XD queries when it comes to applications and other corresponding concerns.
  • Evaluate the legal documents as per FDA requirements, to make sure that all Legal Agreements are valid upon submission to FDA.
  • Keeps up to date with changes in regulatory legislation and guidelines and disseminates the updates to the Regulatory Team.
  • Ensures that quality standards are met and submissions meet strict deadlines for the applications.
  • Assistance and processing of XD, Marketing, and BD requests.
  • Responsible for GMP Clearance Applications and GMP Application Renewals. Ensures that GMP Evidence Dossiers for Non-PICs countries are well evaluated.
  • Responsible for submission of LTO Inclusion.
  • Ensures that the countries, specific fees for applications are paid on time.
  • Performs Quality Assurance on all artwork and ensures that labeling materials comply with FDA requirements and AO
  • Attends to Medical Mission hosted by Ambica International Corporation.
  • Other duties as may be assigned by the management.

Qualification

  • Must be a registered Pharmacist
  • With or w/out work experience in the field of Regulatory
  • Knows how to operate Microsoft Office (MS Word, Excel, Powerpoint, Outlook), and PDF (Nitro Pro, Adobe etc).
  • Good - Excellent English communication skills
  • Able to type fast and accurately
  • Can check documents for grammar, spelling, and punctuation errors
  • Highly self-motivated, goal-oriented, and committed to pursuing a long-term career
  • Exceptionally well organized and strong work ethic

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