Compliance Regulatory Affairs Specialist

Work Schedule

Environmental Conditions

Job Description

Join Thermo Fisher Scientific Inc. a leading company devoted to achieving outstanding outcomes. We are looking for a diligent Compliance Regulatory Affairs Specialist to join our Regulatory Affairs team. You will play a crucial role in ensuring our products meet regulatory standards!

Key Responsibilities

• Work with customers to register Patheon Monza as a manufacturer of sterile medicinal products in the US EU and globally.
• Regulatory Strategy Development: Collaborate with customers to define and implement regulatory strategies for the registration of the Patheon Monza site.
• Documentation Management: Write and review CTD Module 3.2.P Drug Product for new Marketing Authorizations variations renewals and Clinical Trial Applications (CTA).
• Deficiency Letter Response: Assist clients in addressing and responding to Regulatory Authorities Deficiency Letters effectively.
• Legal and External Liaison: Coordinate with the Legal department and external services for notarization legalization and translation activities required for Rest of the World registrations.
• Compliance Assurance: Ensure that manufacturing processes and testing at the Patheon Monza site comply rigorously with the requirements of Marketing Authorizations and CTA.
• Change Control Management: Handle change controls to ensure that registration dossiers and CTA content are accurately reflected in site documentation.
• Conduct gap analyses before inspections. Implement corrective actions with relevant departments.
• Regulatory Support: Provide comprehensive regulatory support to the Patheon Monza site to ensure compliance with relevant legislations (Directives Regulations Italian Laws cGMP ICH/EMA/FDA Guidelines) and company policies.
• Inspection Participation: Actively support and participate in inspections conducted by Regulatory Authorities.

Maintain constantly updated Regulatory Affairs departments databases

Ensure that the Regulatory Affairs departments databases are meticulously maintained and consistently updated to reflect the latest regulatory information and compliance status. This is critical to our magnificent operation and ability to compete in the global market successfully.

Seeking a candidate with passion for regulatory affairs outstanding attention to detail and collaboration skills.