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Ana Micaela Fortin Pharmacist

Philippines Linkedin
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Training and Marketing Professionals Agency

Principal: PFIZER, INC.

Mar (2019) – Current Position: SCESQ Quality Systems & Operational Support Job Description:

Responsible for providing support for managing routine complaints and regulatory  activities. o Collaborates with 15 contract manufacturers (EU) to ensure patients confidence in pharmaceutical products.
Facilitates report  from contract maufacturers in a timely manner. o Drives excellence in Quality by maximizng partner collabotration ( Regulatory and Quality).
May (2017)-Feb (2019) Position: Regulatory Affairs Specialist Job Description:

Prepares submission dossier for license renewals and post-approval changes.
Ensure labeling materials comply with the requirements of both the local health authorities and the company. o Maintain regulatory databases for assigned products. o Check and review batch notification applications for antibiotics prior to submission. o Quality Review of licenses for audit purposes. o Coordinates with the Quality Operations and Supply Chain for the stock release of products. o Monitor document tracking system of submitted Post approval changes to meet the timeline of the project. o Facilitate pending submissions to comply with the allotted period.