Corporate Compliance Officer for Regulatory Affairs

3 settimane fa

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


• Ensure adherence to pharmaceutical quality standards and internal protocols;

• Safeguard the regulatory integrity of production and analytical documentation and processes in relation to Global registration submissions;

• Provide comprehensive regulatory support throughout the Global Products lifecycle (including CMC documentation evaluation, 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 assessing lifecycle changes and facilitate their implementation;

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

Experience Required

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

Education

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

Languages

Proficiency in English (both written and spoken).

Technical Skills


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

• Understanding of reference pharmacopoeia monographs (primarily EP and USP);

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

• Awareness of AIFA regulations;

• Insight into the regulatory framework and registration dossier for Marketing Authorization Holders (MAH).

Soft Skills


• Capacity to adapt 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 with a commitment to meeting deadlines;

• Proficient in establishing effective professional relationships with team members, even in high-pressure situations.

What we offer

Join a vibrant, rapidly evolving, and supportive workplace.
At Chiesi, we recognize that our employees are our greatest asset, which is why we prioritize ongoing training, learning, and development. We are dedicated to promoting and addressing development needs while ensuring a high-quality working environment and collective well-being.
We strive for our employees to feel fulfilled at work every day, understanding the significance of achieving a proper work-life balance to perform at their best. To support this, we provide a flexible working approach, remote work options, assistance with relocation, tax support for international colleagues, and a variety of other employee-focused services.

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