Lavori attuali relativi a Regulatory Affairs Specialist - Monza - Thermo Fisher Scientific
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Regulatory Affairs Specialist
2 mesi fa
Monza, Italia Thermo Fisher Scientific A tempo pieno**Work Schedule** Flex 12 hr shift/days **Environmental Conditions** Office Thermo Fisher Scientific, World Leader in serving Science, is seeking a highly skilled and motivated Regulatory Affairs Specialist to join our team in Monza, Italy. As a Regulatory Affairs Specialist, you will play a crucial role in supporting the registration process of Patheon...
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Regulatory Affairs Manager
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Regulatory Affairs Specialist
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Monza, Italia Thermo Fisher Scientific A tempo pienoThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, growing efficiency in their laboratories,...
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Regulatory Affairs Specialist
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Monza, Italia Thermo Fisher Scientific A tempo pienoThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, growing efficiency in their laboratories,...
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Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoPosition Overview: As a Compliance and Regulatory Affairs Consultant, you will play a pivotal role in ensuring that our manufacturing site adheres to all necessary regulations and standards for sterile medicinal products. Your expertise will guide our clients through the complex landscape of regulatory requirements. Key Responsibilities: Collaborate closely...
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Regulatory Affairs Manager
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Monza, Lombardia, Italia Meet Recruitment Limited A tempo pienoJob DescriptionMeet Recruitment Limited is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our organization, you will be responsible for ensuring the regulatory compliance of our pharmaceutical products.Key Responsibilities:Regulatory Document Management: Compile, review, and submit regulatory documents throughout the...
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Regulatory Affair Manager
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Regulatory Affair Manager
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Monza, Italia Meet Recruitment Inc. A tempo pienoOur client is a prominent organization dedicated to advancing innovative healthcare solutions. With a strong emphasis on regulatory excellence, they are committed to delivering safe and effective medicinal products globally.The Regulatory Affairs Manager will be responsible for managing the regulatory lifecycle of OTC and Consumer products, from initial...
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Regulatory Supervisor
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Regulatory Compliance
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Monza, Italia Thermo Fisher Scientific A tempo pienoThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, growing efficiency in their laboratories, improving...
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Regulatory Compliance
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Monza, Italia Thermo Fisher Scientific A tempo pienoThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, growing efficiency in their laboratories, improving...
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Regulatory Compliance
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Monza, Italia Thermo Fisher Scientific A tempo pienoThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, growing efficiency in their laboratories, improving...
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Equipment Qualification Compliance Specialist
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Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoAbout Thermo Fisher ScientificThermo Fisher Scientific Inc. is a global leader in serving science, with a strong commitment to innovation and customer satisfaction.Our mission is to enable our customers to make the world a better place through scientific excellence and innovation.Job SummaryWe are seeking a highly skilled Equipment Qualification Compliance...
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Regolatore Cosmetico in Formazione
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Regolatore Cosmetico in Formazione
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Quality Assurance Specialist
1 settimana fa
Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoJob Title: Quality Specialist IIThermo Fisher Scientific is seeking a highly skilled Quality Specialist II to join our team. As a Quality Specialist II, you will play a critical role in ensuring the quality of our pharmaceutical products.Responsibilities:Ensure that all production activities are conducted in accordance with current US GMP, EU GMP, and...
Regulatory Affairs Specialist
3 mesi fa
:Support and collaborate with clients for the registration of Patheon Monza site as a manufacturer of sterile medicinal productsAssist clients in defining the regulatory strategy for Patheon Monza site registrationWrite and review CTD Module Drug Product for new Marketing Authorizations, variations, renewals, and Clinical Trials Applications (CTAs)Support clients in responding to Regulatory Authorities Deficiency LettersLead interactions with the Legal department and external services for notarization, legalization, and translation activities for Rest of the World registrationsEnsure compliance with Marketing Authorization/CTA requirements in manufacturing processes and testingLead change controls to ensure the registration dossier/CTA content is acknowledged in Patheon Monza site documentationConduct gap analysis before Regulatory Authority Prior Approval Inspections/clinical batch confirmation and identify appropriate corrective actionsProvide regulatory support to ensure compliance with relevant legislations, guidelines, and company policiesSupport and participate in Regulatory Authorities inspectionsAssist Regulatory Affairs Supervisor and Manager in editing reports requested by the EU Regulatory Affairs function and maintain RA databaseRequirements:Graduation in Chemistry and Pharmaceutical Technology, Pharmacy, Biology, or BiotechnologyConfirmed experience (3 years) in a Regulatory Affairs department for an FDA approved pharmaceutical company, preferably manufacturing sterile productsExpertise in writing/reviewing CTD Module Drug Product for sterile medicinal productsProficiency in EU/US and Rest of the World Submissions and handling documentationFamiliarity with Directives, Regulations, Italian Laws, cGMP, GMP Annex 1, ICH/EMA/FDA GuidelinesGood written and oral English skillsAnalytical, communicative, and relational attitudesThermo Fisher Scientific is an Equal Opportunity Employer.
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