Quality and Regulatory Expert (m/f/d)

Position Overview:
We are seeking a dynamic and detail-oriented Quality Assurance & Regulatory Affairs Expert to join our team. In this role, you will ensure regulatory compliance and quality standards across our pharmaceutical and medical device operations. You will oversee a range of functions including drug and medical device regulatory affairs, pharmacovigilance, safety monitoring, and complaint management. This position will involve direct collaboration with internal and external stakeholders to maintain the highest standards of quality and regulatory compliance.

Your tasks:

Local Drug Regulatory Affairs (LDRA):

• Align with EU and local regulatory requirements while ensuring adherence to internal company policies
• Maintain strong communication with key stakeholders such as the Ministry of Health, AEMPS, and AIFA authorities
• Review and approve local versions of SmPCs, labels, and package leaflets, ensuring regulatory accuracy
• Contribute to the submission of regulatory applications and provide timely, accurate, and compliant responses to regulatory inquiries
• Support the review and approval of promotional materials in line with Farmaindustria, Apifarma Codes, and company policies

Local Medical Device Regulatory Affairs (LMDRA):

• Oversee the registration and maintenance of medical devices, ensuring compliance with registration and regulatory updates
• Respond to regulatory inquiries and support the business by providing expertise in medical device regulations
• Assist in supplier evaluation, regulatory documentation verification, and drafting Quality Assurance Agreements (QAAs)
• Stay current on evolving regulatory and compliance standards

Local Safety Officer (LSO):

• Implement and maintain a medical device vigilance system in compliance with corporate and local regulations
• Lead post-market surveillance activities, reporting incidents, and managing Field Safety Corrective Actions (FSCAs)
• Ensure compliance in distribution and reporting activities, while supporting projects in regulatory, quality, vigilance, and supply chain quality

Pharmacovigilance Person Representative (PVPR):

• Serve as the primary point of contact for pharmacovigilance matters at the national level
• Manage the collection and submission of adverse event (AE) and adverse drug reaction (ADR) reports in accordance with EU regulations
• Implement risk minimization strategies and ensure compliance with corporate pharmacovigilance SOPs
• Oversee local training for pharmacovigilance and contribute to the preparation of quarterly compliance reports
• Coordinate local literature searches and maintain accurate documentation of pharmacovigilance activities

Country Complaint Administrator (CCA):

• Oversee the complaint management process through the QTrack platform
• Liaise directly with end customers to gather information and ensure proper complaint handling
• Provide feedback on incident analysis and follow-up actions

Quality & Regulatory Affairs (Q&R):

• Serve as the Q&R point of contact for assigned tasks, providing strategic recommendations and risk assessments to local and regional management
• Participate in internal and external audits, conducting supplier audits where necessary

Good Distribution Practices (GDP):

• Ensure compliance with GDP regulations for the storage and distribution of pharmaceutical products, maintaining the highest standards in distribution practices

Your profile:

• Bachelor’s degree in Pharmacy, Chemical, Bioengineering, Health Sciences, or a related scientific discipline
• Minimum of 4 years of professional experience in regulatory affairs, pharmacovigilance, and medical device regulation. Experience in quality assurance is a plus
• In-depth knowledge of pharmaceutical regulations and drug registration dossiers in CTD format
• Strong understanding of medical device regulations (MDD/MDR) and local healthcare systems
• Familiarity with ISO 9001/ISO 13485 Quality Management Systems and Good Distribution Practices (GDP)
• Proficiency in English, Italian, and/or Spanish (both written and spoken)
• Excellent communication, organizational, and analytical skills, with a meticulous attention to detail and commitment to quality