Regulatory Pharmacist

Ambica International Corporation; Pasay; On-site; PHP 223,200 - 334,800; Full time

Job summary

A pharmaceutical company in Pasay is seeking a Registered Pharmacist to ensure compliance with FDA guidelines and handle regulatory submissions. The role entails preparing documents, communicating with suppliers, and keeping updated with regulatory changes. Experience in regulatory fields is preferred, though not required. The ideal candidate should possess strong organizational skills and proficiency in Microsoft Office.

Qualifications

• Must be a registered Pharmacist.
• With or without work experience in Regulatory.
• Able to type fast and accurately.

Responsibilities

• Ensure compliance of documents per FDA Guidelines.
• Prepare documents for regulatory purposes and submissions.
• Communicate with suppliers and prepare submissions for FDA.

Skills

Microsoft Office (MS Word, Excel, Powerpoint, Outlook)

Document review

Self-motivated

Organization

Education

Registered Pharmacist

Tools

Nitro Pro

Adobe PDF

Job description

On-site - Pasay No Exp Required Bachelor Full-time

Job Description

• 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 2016-0008.
• ends to Medical Mission hosted by Ambica International Corporation.
• Other duties as may be assigned by the management.

Qualifications

• 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).
• 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