Sr. Spclst, Regulatory Affairs

Job Description

An amazing opportunity has arisen for a Quality & Regulatory Specialist in our company Animal Health Portugal.

This position will be responsible for supporting Quality and Regulatory activities across incoming goods and distribution operations, ensuring compliance with applicable standards and requirements.

Working with cross-functional teams and external logistics partners, the role will contribute to Quality System performance, compliance monitoring, and key regulatory submissions and product maintenance activities.

What you will do:  

Bring energy, knowledge, innovation and leadership to carry out the following:

• Review and approve Quality documentation for incoming goods, ensuring accurate records retention in line with Good Documentation Practices, and verifying transportation conditions from the manufacturing site.
• Manage and track Quality System activities including deviations, CAPA, change controls, customer qualification requests, and returned goods.
• Prepare Quality Metrics, contribute to the Quality System Review, and participate in 3PL compliance monitoring.
• Execute quality activities required by Good Distribution Practices, Corporate Policies, and applicable EU regulatory requirements for products marketed by our company Animal Health Portugal.
• Ensure timely preparation, submission, and follow-up of Marketing Authorization applications, and maintain authorized products through variations, renewals, and supplemental authorizations.
• Ensure timely, accurate, and compliant labelling translations and artwork preparation, partnering with cross-functional teams to implement local regulatory strategies and manage regulatory risks.

What skills you will need:

In order to excel in this role, you will more than likely have:

• Review and approve Quality documentation for all incoming goods, verify transportation conditions from the manufacturing site, and ensure accurate documentation and record retention in line with Good Documentation Practices.
• Manage and track Quality System activities, including internal deviations, CAPA, change controls, customer qualification requests, returned goods, and other related activities.
• Prepare Quality Metrics, contribute to the Quality System Review, and support 3PL compliance monitoring.
• Execute quality activities required by Good Distribution Practices, Corporate Policies, and applicable EU regulatory requirements for products marketed by our company Animal Health Portugal.