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. 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. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own.

Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth. 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 [email protected].

📌 Regulatory Specialist and Senior Specialist (Milano)
🏢 Sobi - Swedish Orphan Biovitrum AB (publ)
📍 Milano