Regulatory Pharmacist - mervillle parañaque cityAmbica International Corporation

REGULATORY PHARMACIST:
Requirements:
Must be a licensed/registered Pharmacist with good scholastic record.
Preferably with work experience in the Regulatory field, but fresh graduates and no experience in Regulatory can still be accommodated.
Must have excellent analytical and critical thinking skills and has the ability to handle and process lots of information. Willing to be trained and is fast learner, goal-oriented and committed in pursuing long term career within the company.
Must have good written and spoken communication skills and ability to multitask as well as work independently and under pressure.
Meticulous and keen to details.
Proficient in the use of digital tools/systems.
Responsibilities:
Responsible in the preparation, evaluation, communication with suppliers and ensuring the correctness and consistency of necessary documents in accordance to the requisites of the local pharmaceutical regulatory per FDA guidelines for filing/submission of all FDA-related applications such as but not limited to Initial applications, Biologicals Drug Applications, Foreign GMP Clearance Applications, Variations, Notifications and Renewal Applications to be able to secure approval.
Responsible in ensuring that all product registrations, licenses and Certificate of GMP Compliances are valid and submitted to FDA for renewal prior to its expiration date.
Performs quality assurance on all artworks and labels in compliance with FDA local regulations and corporate policies.
Performs regulatory-assigned activities and roles in support of business objective.
Summary of role requirements:
Looking for candidates available to work on weekdays
No experience required for this role
Working rights required for this role