Associate Director - Regulatory, PV & Quality

Sobi; Italia; In loco; EUR 70.000 - 100.000; Tempo pieno

Descrizione del lavoro

A leading international pharmaceutical company is seeking an Associate Director - Regulatory, PV & Quality in Italy, to oversee critical operations including regulatory affairs and quality assurance. This role requires significant expertise, collaboration with regulatory authorities, and leadership in influencing compliance processes to enhance patient care. Ideal candidates should possess an advanced degree, extensive industry experience, and strong communication skills.

Competenze

• 10+ years of experience in the pharmaceutical industry.
• Solid understanding of Regulatory Affairs and Pharmacovigilance rules.
• Experience in new product launches.

Mansioni

• Oversee Regulatory Affairs, Pharmacovigilance, and Quality Assurance activities.
• Liaise with AIFA and manage lifecycle of drugs.
• Ensure compliance and maintain standard operating procedures.

Conoscenze

Regulatory Affairs

Pharmacovigilance

Quality Assurance

Project Management

Interpersonal Communication

Strategic Thinking

Formazione

Advanced degree (MSc/PhD) in science or business

Strumenti

Microsoft Office

modern software tools

Descrizione del lavoro

Associate Director - Regulatory, PV & Quality

• Full-time

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.

We’re looking for anAssociate Director - Regulatory, PV & Qualityto join our team in Italy!

In this role, you’ll overseeRegulatory Affairs,Pharmacovigilance (PV), andQuality 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 theQA responsible(external consultant)and thelocal PV contact point (externalconsultant).
• Report directly to theGeneral Manager.

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 theNational Healthcare System,Regulatory Affairs, andPharmacovigilance rules.
• Proven experience innew product launchesandscientific information material reviews.
• A strongbusiness partnership approach, with the ability to collaborate effectively across teams.
• Demonstratedethicsandproject management skills.
• Ability to build relationships and networks withnational Regulatory Authorities.
• Proficient in Microsoft Office and modern software tools.

Personal Skills:

• Excellentinterpersonal and communication skills, with the ability to influence and work effectively in a matrix organization.
• Strategic thinker with stronganalytical and conceptual skills.
• Results-driven, with aproblem-solving mindsetand the ability to balance both the big picture and detailed execution.
• Strong organizational skills, with the ability tocoordinate resources and projects, ensuring accountability and timely delivery.
• A role model aligned withSobi’s values, fostering a culture of continuous improvement.

Languages:

• Strong written and spoken English is required.