Work Schedule
Flex 12 hr shift/days

Environmental Conditions
Office

Job Description

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 Monza site as a manufacturer of sterile medicinal products in the main markets (US, EU, and Rest of the World). This is an outstanding opportunity to work with extraordinary clients and contribute to the development and implementation of regulatory strategies.

Responsibilities:

• Support and collaborate with clients for the registration of Patheon Monza site as a manufacturer of sterile medicinal products
• Assist clients in defining the regulatory strategy for Patheon Monza site registration
• Write and review CTD Module 3.2.P Drug Product for new Marketing Authorizations, variations, renewals, and Clinical Trials Applications (CTAs)
• Support clients in responding to Regulatory Authorities Deficiency Letters
• Lead interactions with the Legal department and external services for notarization, legalization, and translation activities for Rest of the World registrations
• Ensure compliance with Marketing Authorization/CTA requirements in manufacturing processes and testing
• Lead change controls to ensure the registration dossier/CTA content is acknowledged in Patheon Monza site documentation
• Conduct gap analysis before Regulatory Authority Prior Approval Inspections/clinical batch confirmation and identify appropriate corrective actions
• Provide regulatory support to ensure compliance with relevant legislations, guidelines, and company policies
• Support and participate in Regulatory Authorities inspections
• Assist Regulatory Affairs Supervisor and Manager in editing reports requested by the EU Regulatory Affairs function and maintain RA database

• Graduation in Chemistry and Pharmaceutical Technology, Pharmacy, Biology, or Biotechnology
• Confirmed experience (3 years) in a Regulatory Affairs department for an FDA approved pharmaceutical company, preferably manufacturing sterile products
• Expertise in writing/reviewing CTD Module 3.2.P Drug Product for sterile medicinal products
• Proficiency in EU/US and Rest of the World Submissions and handling documentation
• Familiarity with Directives, Regulations, Italian Laws, cGMP, GMP Annex 1, ICH/EMA/FDA Guidelines
• Good written and oral English skills
• Analytical, communicative, and relational attitudes