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, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease. Why Join Us? 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. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you. We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff. Sobi Culture At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them. As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth. An Equal Opportunity Employer Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate. Sobi is an affirmative action and equal opportunity employer. Disabled/Veterans. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to . 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