Site Regulatory Compliance Associate
Overview We are seeking a highly organized and detail-oriented Site Regulatory Compliance Associate to join our team. The role is involved in the operational and regulatory document management of the Quality Assurance Department. Involvement in "Global" projects is also possible. He /she will report to the Change and Supplier Manager.
Main Activities & Responsibilities
The candidate will mainly focus on the following activities:
1. Site Regulatory Affairs and Liaison with Authorities
- Management of official correspondence, GMP communications, and administrative procedures with AIFA (Italian Medicines Agency).
- Preparation, submission, and management of Regulatory Applications for the presentation of “Essential” and “Non-Essential” changes.
- Monitoring the progress of approval procedures, ensuring compliance with company and regulatory timelines.
- Supporting the activities of the Qualified Person (QP).
2. QA Compliance and Change Management
- Evaluation and management of site Change Controls, identifying and analyzing any potential regulatory impact.
- Technical-regulatory support in managing and evaluating Deviations and Complaints that involve compliance implications or authorization variations.
- Verifying that site activities are aligned with the Marketing Authorization Dossier requirements.
Main Activities & Responsibilities
The candidate will mainly focus on the following activities:
1. Site Regulatory Affairs and Liaison with Authorities
- Management of official correspondence, GMP communications, and administrative procedures with AIFA (Italian Medicines Agency).
- Preparation, submission, and management of Regulatory Applications for the presentation of “Essential” and “Non-Essential” changes.
- Monitoring the progress of approval procedures, ensuring compliance with company and regulatory timelines.
- Supporting the activities of the Qualified Person (QP).
2. QA Compliance and Change Management
- Evaluation and management of site Change Controls, identifying and analyzing any potential regulatory impact.
- Technical-regulatory support in managing and evaluating Deviations and Complaints that involve compliance implications or authorization variations.
- Verifying that site activities are aligned with the Marketing Authorization Dossier requirements.