Regulatory Compliance Specialist in Pharmaceuticals
3 settimane fa
• Ensure adherence to pharmaceutical standards and internal protocols;
• Safeguard the regulatory integrity of production and analytical documentation and processes in line with Global registration requirements;
• Provide comprehensive regulatory support throughout the Global Products life-cycle (including CMC documentation evaluation, responses to deficiency letters, and documentation for initial registration);
• Oversee quality activities related to the Global Products lifecycle (such as item code attributes in the SAP system and materials specifications in the LIMS system);
• Assist in assessing life-cycle changes and facilitating their implementation;
• Act as a liaison between manufacturing facilities (both internal and external) and Global Regulatory Affairs.
A minimum of 4-5 years of experience in Regulatory or Quality Assurance roles within the pharmaceutical sector.
EducationDegree in scientific fields (such as Chemistry, Biology, Pharmacy, or related disciplines).
LanguagesProficiency in English (both written and verbal).
Technical Skills
• Familiarity with relevant national and international regulations (including EMA, FDA, ICH guidelines, etc.);
• Understanding of reference pharmacopoeias (primarily EP and USP);
• Knowledge of GMP and Quality Management Systems;
• Awareness of AIFA regulations;
• Insight into the regulatory framework and registration dossier for Marketing Authorization Holders (MAH).
• Capability to adapt quickly to new, dynamic, and multicultural work environments;
• Problem-solving mindset and flexibility in exploring new solutions and alternative pathways;
• Strong organizational and time management abilities;
• Goal-oriented approach with a commitment to meeting deadlines;
• Proficiency in fostering positive professional relationships with team members, even in high-pressure situations.
What we offer
Join a vibrant, rapidly evolving, and supportive environment at Chiesi. We firmly believe that our employees are our greatest asset, which is why we prioritize continuous training, learning, and development. We are dedicated to addressing development needs while emphasizing the quality of our work environment and collective well-being.
We aspire for our employees to arrive at work with enthusiasm each day, recognizing the importance of achieving a healthy 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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