Regulatory Specialist and Senior Specialist
Pubblicato il 27-09-2026 - Sobi - Swedish Orphan Biovitrum AB (publ) in Italia
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