Regulatory Affairs Specialist
3 settimane fa
Thermo 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, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global organization of more than 100,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
**Main responsibilities**
Support and interact with Clients for the registration of Patheon Monza site as manufacturer of sterile medicinal products for commercial/clinical use in the main markets (US, EU and Rest of the World).
Support Clients in defining the regulatory strategy for Patheon Monza site registration.
Writing/review of CTD Module 3.2.P Drug Product for new Marketing Authorizations, variations and renewals and for CTA.
Support Clients in answering to Regulatory Authorities Deficiency Letters.
Manage interactions with Legal department and external services for notarization, legalization, translation activities for Rest of the World registrations
Guarantee that Patheon Monza site manufacturing processes and testing are performed in compliance with the requirements of Marketing Authorizations/CTA.
Assure that the content of the registration dossiers/CTA is acknowledged in Patheon Monza site documentation through change controls'' management.
Issue gap analysis before a Regulatory Authority Prior Approval Inspections/clinical batches batch confirmation and identify if required any appropriate corrective actions interacting with the relevant departments.
Provide regulatory support to Patheon Monza site in order to guarantee the compliance with legislations (Directives, Regulations, Italian Laws, cGMP, ICH/EMA/FDA Guidelines)/Company''s policies
Support and participate to Regulatory Authorities inspections.
Maintain constantly updated Regulatory Affairs department''s databases.
**Requirments**
Graduation in Chemistry, CTF, Pharmacy or Biology.
At least 3 years of experience in a Regulatory Affairs role in FDA approved pharmaceutical industry, preferably manufacturing sterile products
Standard knowledge of pharmaceutical technology and of analytical techniques
Knowledge of cGMP, Guidelines, CFR
Good knowledge in written and oral English
Analytical attitudes
Communicative attitudes
Respectful and flexible attitude, high engagement and self motivation, attitude to meet deadlines
Relational attitude
Deep empathy
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
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