Technical Cmc Specialist
2 settimane fa
**The contex/Company description** Recordati, established in 1926, is an international pharmaceutical group, listed on the Italian Stock Exchange (Reuters RECI.MI, Bloomberg REC IM, ISIN IT 0003828271), with a total staff of more than 4,300, dedicated to the research, development, manufacturing and marketing of pharmaceuticals. Headquartered in Milan, Italy, Recordati has operations in Europe, Russia and the other C.I.S. countries, Ukraine, Turkey, North Africa, the United States of America, Canada, Mexico, some South American countries, Japan and Australia. An efficient field force of medical representatives promotes a wide range of innovative pharmaceuticals, both proprietary and under license, in several therapeutic areas including a specialized business dedicated to treatments for rare diseases. Recordati is a partner of choice for new product licenses for its territories. Recordati is committed to the research and development of new specialties with a focus on treatments for rare diseases. **Your contribution/mission** As Technical CMS Specialist you will write and manage technical sections of Module 3 (and IMPD) in collaboration with the different departments and you will assess the technical gaps associated with existing products, processes and methods (Gap Analysis). You will make evaluations of technical reports (Process Validation Protocols & Reports, Analytical Methods Validation, AMT, Development Reports) and you will also know how to translate these reports into regulatory documents suitable for submission to the Regulatory Authorities. In addition, you have to verify the Module 3 of existing products in order to predict the potential future regulatory impact associated with those products and related variations. **Your profile** You have a previous business experience (eg manufacturing Compliance, Regulatory CMC) as Specialist in the Regulatory CMC sector with an extremely technical cut - 3/5 years Thanks to your proved experience you are able to understand and deal with the "intelligent and targeted" writing of a section of Module 3 in order to place in the correct information expected by Regulatory Authorities. You have deep knowledge of the guidelines governing the CMC sector, such as ICH Q, EMA Quality guidelines, WHO guidelines and you are able to interpret these guidelines according to the product to be managed. Your English if fluent. **Additional information** Location: Milan, Italy Direct Manager: Regulatory Affairs Manager - Industrial - “At Recordati, we believe in equal opportunities and we guarantee that everyone can achieve their potential. We see diversity as a value and will not tolerate any discrimination based on ethnicity, nationality, gender, sexual orientation, disability, age, political or religious belief, or any other personal characteristics. At Recordati, we work hard to create a safe and inclusive work environment, where we all have our rights to physical and psychological integrity respected on a daily basis, as well as our right to freedom of opinion and association. We recognise that we each have a role to play in the success of our business and we implement staff development policies through which everyone's contribution and achievements can be appropriately rewarded.”_
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CMC Specialist
2 settimane fa
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Cmc Specialist
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Milano, Italia Technical Hunters Srl A tempo pienoLuogo di lavoro: Monza e Della Brianza Per conto di una azienda in forte crescita operante nel settore delle biotecnologie, stiamo ricercando una figura di CMC Specialist.ResponsabilitàElaborare le informazioni relative agli adempimenti regolatori riferiti alla CMC necessari all'attuazione dei piani aziendali;Redigere i documenti CMC necessari per la...
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