Regulatory Specialist and Senior Specialist

Company Description
Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. We are an Equal Opportunity Employer and value diversity at all levels of the organization. Applications from candidates belonging to protected categories under Italian Law 68⁄99 are welcome.
We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Opportunities for professional growth
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.
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
Support the implementation and maintenance of local Pharmacovigilance processes in accordance with global procedures, local regulations and Good Pharmacovigilance Practices (GVP).
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. 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.
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.
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:
Competitive benefits package
We are a global company with over 1,900 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. We offer a competitive benefits package, to support the health and happiness of our staff.
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