Global Quality Regulatory API Specialist

Overview

Today, we are a pharmaceutical group with a track record spanning over 45 years and a footprint in more than 50 countries, led by Leandro and Lucas Sigman. Our overarching goal is to improve people's health all over the world, providing accessible, effective, safe, quality medicines through our various business units, underpinned by continuous investment in R&D and cutting-edge technology at all our centres.

General Responsibilities

Support the Global API Quality and Regulatory Director in evaluating the current requirements of the Regulatory Agencies, for API CMOs and JVs sites, specifically from chemistry and solid-state perspective.

The candidate will collect the necessary information and documents from the manufacturers, review them from chemistry and solid-state perspective, and will interact, with the support of the Global API Quality and Regulatory Director, with the manufacturing sites, or as support in case of interactions with the Authorities.

The candidate will contribute to respond to the queries received from the Regulatory Agencies and Customers from chemistry and technical perspective.

The candidate will support the Global API Quality and Regulatory Director in defining the strategies for replying to Deficiency Letters of Customer technical requests.

Responsibilities

• Collect the information about manufacture and controls of the APIs to the manufacturers and verify the adequacy for the initial filings, as well for answering the deficiency letters, specifically from chemistry and solid-state perspective.
• As process leader keep monitored the process lifecycle from chemistry perspective in all the changes proposed and implemented.
• Support the head of the function in implement and report as head of projects that the priorities established are afforded and without unknown concern, specifically from chemistry and solid-state perspective.
• Support the head of the function in complaints and customer technical requests.
• Follow up of the milestones of the projects, by periodical meetings and reporting.
• Support the organization with interdepartmental teams meeting for implementing the strategies defined along with the Global API Quality and Regulatory Director.

Qualifications

Seniority level

Employment type

Job function

Industries

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