Corporate Compliance Officer for Regulatory Affairs

4 settimane fa

Parma, Emilia-Romagna, Italia Chiesi Group A tempo pieno
Who we are looking for Key Responsibilities


• Ensure adherence to pharmaceutical quality standards and internal protocols;

• Safeguard the regulatory integrity of production and analytical documentation and processes in alignment with Global registration requirements;

• Provide comprehensive regulatory support throughout the Global Products lifecycle (including CMC documentation review, responses to deficiency letters, and documentation for initial registration);

• Oversee quality activities related to the lifecycle of Global Products (such as item code attributes in the SAP system and material specifications in the LIMS system);

• Assist in evaluating lifecycle changes and facilitate their implementation;

• Act as a liaison between manufacturing facilities (both internal and external) and Global Regulatory Affairs.

Required Experience

A minimum of 4-5 years of experience in Regulatory Affairs or Quality Assurance roles within the pharmaceutical sector.

Educational Background

Degree in scientific fields (such as Chemistry, Biology, Pharmacy, or related disciplines).

Language Proficiency

Proficient in English (both written and spoken).

Technical Expertise


• Familiarity with relevant national and international regulations (including EMA, FDA, ICH guidelines, etc.);

• Understanding of reference pharmacopoeias (primarily EP and USP);

• Knowledge of Good Manufacturing Practices (GMP) and Quality Systems;

• Awareness of AIFA regulations;

• Comprehension of the regulatory framework and registration dossier for Marketing Authorization Holders (MAH).

Interpersonal Skills


• Capacity to adapt quickly to new, dynamic, and multicultural work environments;

• Problem-solving mindset and flexibility in exploring new solutions and alternative approaches;

• Strong organizational and time management abilities;

• Goal-oriented perspective with a commitment to meeting deadlines;

• Ability to foster positive professional relationships with team members, even in high-pressure situations.

What we offer

Join a vibrant, rapidly expanding, and supportive environment at Chiesi. We believe that our employees are our greatest asset, which is why we prioritize ongoing training, learning, and development. We are dedicated to addressing development needs while ensuring a high-quality working environment and collective well-being.
We aim for our employees to feel fulfilled at work every day, recognizing the importance of achieving a healthy work-life balance to perform at their best. To support this, we provide a flexible working model, remote work options, assistance with relocation, tax support for international colleagues, and a variety of employee-focused services.

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