Regulatory Affairs Specialist
Thermo Fisher Scientific
- Monza
- Tempo indeterminato
- Full time
- 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.
- Write and review of CTD Module 3.2.P Drug Product for new Marketing Authorizations, variations and renewals and for Clinical Trials Applications (CTAs).
- Support Clients in answering to Regulatory Authorities Deficiency Letters.
- Lead 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 Authorization/CTA.
- Assure that the content of the registration dossier/CTA is acknowledged in Patheon Monza site documentation through change controls' management.
- Issue gap analysis before a Regulatory Authority Prior Approval Inspection/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.
- Support to Regulatory Affairs Supervisor and to Regulatory Affairs Manager for the editing of reports requested by the EU Regulatory Affairs function.
Proven experience (3 years) in a Regulatory Affairs department for a FDA approved pharmaceutical company, preferably manufacturing sterile products.Expertise in writing/review of CTD Module 3.2.P Drug Product for sterile medicinal products.Expertise in EU/US and Rest of the World Submissions and in managing of documentation (including interaction with notary for notarizations/legalizations and with internal departments/external suppliers)
Standard knowledge of pharmaceutical technology and of analytical techniques
Knowledge of Directives, Regulations, Italian Laws, cGMP, GMP Annex 1, ICH/EMA/FDA GuidelinesGood knowledge in written and oral English
Analytical attitudes
Communicative attitudes
Supportive and flexible attitude, high engagement and self-motivation, demeanor to meet deadlines
Relational attitude
Deep emotional intelligenceThermo 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.Join Us!