Regulatory Pharmacist for Makati - Direct Hire

URGENT ! ! ! DIRECT HIRE ! ! !

Qualifications
• Licensed Pharmacist and familiar with FDA and PDEA ruling
• With more than 2 years of work experience in the field of Regulatory
• Possesses good interpersonal and communication skills
• Attentive to details, analytical, and result-oriented
• Excellent oral and written communication skills
• Hard-working, result-oriented and strong drive to succeed
• Willing to do fieldwork/ leg work
• Willing to assign in Makati and Batangas
JOB DESCRIPTION
• Responsible for ensuring the compliance of the documents per FDA Guidelines for the Initial Applications for Medical Device & 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 Medical Device Initials, and Notifications.
• Responsible for renewal and revalidation of LTO & Certificate of Product Registration
• Communicates with the suppliers, evaluates and prepares the requirements for CMDN/ CMDR submission.
• Responsible for variation/amendment applications of Certificate of Product Registration.
• Responsible in having follow-ups for the applications that were not yet evaluated by FDA for timely release of approval from FDA.
• Able to submit compliance on or before the deadline as prescribed by FDA.
• Prepares documents for regulatory purposes/FDA concerns such as LTO application and LTO Renewal.
• Responds to clients queries when it comes to applications and other corresponding concerns.
• Evaluates legal documents as per FDA requirements, makes 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 Regulatory Team.
• Ensures that quality standards are met and submissions meet strict deadlines for the applications.

Job Location: Makati City & Batangas City
Salary Range: 20,000 – 30,000

*bap