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.

3. Global Interface and Dossier Management

• Direct collaboration and interfacing with the Global QA Regulatory Compliance department for sharing, reviewing, and updating variations to be made to Module 3 of the Registration Dossier.

• Verifying the correct flow of information between the manufacturing plant and global regulatory functions.

4. Additional Activities

• Provide support to the auditing team during internal or external audit preparation and readiness activities related to regulatory compliance.

• Provide support in supplier qualification, process validation, CAPAs and Quality System KPIs, as well as continuous improvement activities; drafting and reviewing documentation related to the company Quality System.

Job Requirements

• Education: Degree in technical/scientific disciplines (preferably CTF/Pharmaceutical Chemistry and Technology, Pharmacy, or Chemistry).

• Languages: Fluent written and spoken English.

• Experience: Experience in the regulatory sector of pharmaceutical manufacturing (at least 3 years); knowledge of main AIFA procedures and practices.

• Eligibility to act as a Qualified Person.

• Soft Skills:

  • Excellent interpersonal and communication skills to interface effectively with various internal (Production, QA, Global, Regulatory Affairs) and external stakeholders.
  • Strong motivation, proactivity, precision, problem-solving attitude, strong goal-orientation, and a "lean" approach.
  • Leadership skills and assertiveness, with a determined and dynamic character.
  • Good relationship skills, flexibility, and willingness to travel.
  • Strong sensitivity to quality KPIs and continuous improvement topics.
  • Planning and organizational skills.
  • Proficiency in using spreadsheet and statistical processing software

The selected candidate will be employed under Category C in accordance with the provisions of the current National Collective Bargaining Agreement (CCNL) for the Chemical and Pharmaceutical Industry, including all applicable contractual and remuneration terms, and in compliance with Legislative Decree No. 96/2026.