Regulatory Specialist

Company Description Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application 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. At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients. Here At Sobi, Our Mission And Culture Get Us Excited To Come To Work Every Day, But Here Are a Few More Reasons To Join Our Team

• Competitive compensation for your work
• Emphasis on work/life balance
• Collaborative and team-oriented environment
• Opportunities for professional growth
• Diversity and Inclusion
• Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

Job Description 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.

Qualifications 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 i