Associate Director - Regulatory, PV & Quality

Company Description

Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.

Job Description

We’re looking for an Associate Director - Regulatory, PV & Quality to join our team in Italy!

In this role, you’ll oversee Regulatory Affairs, Pharmacovigilance (PV), and Quality Assurance (QA) activities, working closely with external vendors and consultants to ensure compliance and excellence. You’ll also collaborate with cross-functional teams and act as the primary point of contact with regulatory authorities, making a real difference in the lives of patients.

What You’ll Do:

Regulatory Affairs:

• Be the go-to person for regulatory matters, liaising with AIFA and managing the lifecycle of drugs and medical devices.
• Provide guidance to internal teams and ensure compliance with local regulations.
• Review promotional and non-promotional materials to meet Italian legislative requirements.
• Support audits and maintain standard operating procedures for regulatory activities.

Pharmacovigilance (PV):

• Ensure global and local PV requirements are met, including safety data reporting, monitoring local legislation, and managing PV agreements.
• Directly responsible for the strict oversight of the activities performed by the Local/Global external vendor managing PV.
• Oversee risk management activities and support audits and inspections.

Quality Assurance (QA):

• Oversee GxP/QA activities performed by external consultants, ensuring compliance and high standards.

Who You’ll Work With:

• Directly manage the QA responsible (external consultant) and the local PV contact point (external consultant).
• Report directly to the General Manager.

Qualifications

What We’re Looking For:

Experience & Knowledge:

• Advanced degree (MSc/PhD) in science or business preferred.
• 10+ years of experience in the pharmaceutical industry.
• Solid understanding of the National Healthcare System, Regulatory Affairs, and Pharmacovigilance rules.
• Proven experience in new product launches and scientific information material reviews.
• A strong business partnership approach, with the ability to collaborate effectively across teams.
• Demonstrated ethics and project management skills.
• Ability to build relationships and networks with national Regulatory Authorities.
• Proficient in Microsoft Office and modern software tools.

Personal Skills:

• Excellent interpersonal and communication skills, with the ability to influence and work effectively in a matrix organization.
• Strategic thinker with strong analytical and conceptual skills.
• Results-driven, with a problem-solving mindset and the ability to balance both the big picture and detailed execution.
• Strong organizational skills, with the ability to coordinate resources and projects, ensuring accountability and timely delivery.
• A role model aligned with Sobi’s values, fostering a culture of continuous improvement.

Languages:

• Strong written and spoken English is required.