Regulatory Specialist

The Regulatory Affairs Specialist provide regulatory and operational support across a broad range of activities, ensuring that medicinal products and medical devices, where applicable, remain compliant with Italian and European regulatory requirements throughout their lifecycle. Reporting to the Regulatory Affairs, Quality Assurance & Pharmacovigilance Associate Director, will work closely with internal departments and external stakeholders and will contribute to the maintenance of product compliance, support regulatory submissions, and ensure adherence to applicable regulatory and local pharmacovigilance requirements. Key Responsibilities Regulatory Affairs Responsibilities Support the local implementation and maintenance of centrally authorized products, ensuring compliance with Italian regulatory requirements and effective coordination with Global Regulatory Affairs for all EMA-managed procedures. Manage local product lifecycle activities, including the implementation of variations, renewals, notifications, and other post-approval changes, in close collaboration with Global Regulatory Affairs and relevant stakeholders. Support the local review and approval of translated product information texts, packaging artworks, ensuring timely and compliant implementation. Collaborate in reviewal and approval of promotional and non-promotional materials to ensure compliance with applicable regulations and company procedures, in collaboration with RSS. Maintain accurate regulatory documentation and ensure timely updates to internal systems and databases, in accordance with company requirements. Provide support to internal stakeholders (commercial, medical, access) on local regulatory requirements and procedures, to support business objectives while maintaining regulatory compliance. Support Regulatory Intelligence activities by monitoring changes in applicable regulations, guidelines and industry practices. Support the implementation, maintenance and distribution of Risk Management Plan (RMP) educational materials in collaboration with Medical Affairs. Contribute to the development, maintenance and periodic review of local Standard Operating Procedures (SOPs), Working Instructions and Regulatory Affairs processes Pharmacovigilance Support Support the implementation and maintenance of local Pharmacovigilance processes in accordance with global procedures, local regulations and Good Pharmacovigilance Practices (GVP). Assist in managing Pharmacovigilance-related agreements with External Service Providers (ESPs). Support inspections, audits and compliance checks related to Pharmacovigilance activities. Education/Learning Experience/Work Experience Bachelor’s or master’s degree in pharmacy, Pharmaceutical Chemistry and Technology (CTF), Life Sciences, Biotechnology, Medicine or related scientific discipline. Master’s degree in Regulatory Affairs and/or Market Access is considered a plus. 2–5 years of experience in Regulatory Affairs within the pharmaceutical industry. Experience of promotional material review processes is preferred. Personal Skills/Knowledge/Languages Effective cross-functional collaboration and communication skills. Strong organizational skills and attention to detail. Ability to manage multiple priorities and deadlines. Fluent Italian and English, both written and spoken. Proficiency in Microsoft Office applications. Ability to work independently while maintaining strong collaboration with the RA/QA/PV Associate Director and cross-functional teams. Compensation and Total Rewards at Sobi At Sobi, we are dedicated to providing our employees with a comprehensive and industry-competitive total rewards package. Our compensation philosophy recognizes and rewards talent and ensures that employee contributions are valued and reflected in overall rewards. Sobi is looking for a resource for the role of Regulatory Specialist For this position, we are offering: Permanent employment contract Full-time (39 hours per week) The salary range for this role is €38,000 to €50,000 gross per year, depending on the candidate’s level of experience, seniority, and demonstrated competencies. Short Term Incentive: participation Incentive Plan program Applicable collective agreement: Chemical-Pharmaceutical Health insurance: Enrollment in the Faschim industry health fund covering the employee and their family Annual welfare plan Accident and life insurance policies Beyond compensation, Sobi offers a variety of benefits designed to support employee wellbeing and professional growth, including: The opportunity to make a meaningful impact for people living with rare and severe diseases Competitive benefits package Emphasis on employee engagement Collaborative, inclusive, high-performance culture Work in an environment of entrepreneurial speed and drive Opportunities for development through a learning culture in a global growing company All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition,…