Who we are? 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 Responsibility: Support the Global API Quality and Regulatory Director in evaluating the current requirements of the Regulatory Agencies, for what refers 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.
Specific 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 implementing and reporting 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 on the milestones of the projects, by periodical meetings and reporting. Support the organization with interdepartmental team meetings for implementing the strategies defined along with the Global API Quality and Regulatory Director. Qualifications: Education: University Level in Pharmacy, Chemistry, or other relevant Science discipline. Languages: Fluent English and Spanish. Experience: 2-5 years experience with technical quality documentation elaboration in a regulated environment (GxP). Preferable in the Chemistry and Solid-State areas. Specific Knowledge: Advanced Microsoft platform processing user. Travels: not expected. Personal Skills: Autonomy, precision, hands-on hard worker, good communicator and technical writer, ability to interact with multicultural and international remote teams, interested in team working.
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