Regulatory & Reimbursement Affairs Manager       

Are you ready to make a significant impact in the pharmaceutical industry?

As a Regulatory & Reimbursement Affairs Manager, you will ensure compliance with GRP, Local and Global SOPs, MC Regulatory Process and Quality Manual, and Italian and European regulations. You will facilitate the flow of information between the Italian Medicines Agency (AIFA) and various departments, evaluate risks and opportunities on reimbursement agreements, and support the team in preparing and monitoring P&R applications. Your role will be crucial in maintaining compliance and supporting the lifecycle management of AZ medicinal products.

Accountabilities

• Guarantee the maintenance and compliance to GRP with a specific responsibility to:
  - Supervise and assure the compliance of regulatory knowledge traceability
  - Assure proper archiving of all relevant documents related to regulatory activities
  - Ensure that Global Standard Operating Procedure (SOPs) and guidance are adopted in local SOPs
• Actively participate in business product teams
• Engage in local and international meetings
• Estimate the TTM for AZ products and competitors
• Support Market Access and Marketing teams for P&R dossier submissions
• Manage special projects like MA transfer
• Oversee other regulatory associates for the above-mentioned activities
• Provide effective lobbying and interactions with AIFA and trade associations on product and legislative development issues
• Represent AstraZeneca in relations with AIFA through meetings and telephone contacts
• Ensure follow-up of regulatory submissions to AIFA and maintain AZ policy on lifecycle management of products
• Maintain adequate documentation of correspondence between AIFA and AZ
• Monitor progress of P&R applications filed in AIFA
• Manage periodic monitoring documents on agency activities
• Analyze emerging trends in interactions with AIFA and support registration and reimbursement of AZ products
• Participate in cross-functional projects within the performance management process

Essential Skills/Experience

• University Degree in Science or related discipline
• Good knowledge of National and EU pharmaceutical legislation
• Experience in an area of regulatory affairs 
• Professional culture in pharmaceutical policy and regulatory affairs 
• Experience of working on cross-functional teams
• Prior pharmaceutical industry experience
• Good written and verbal communication skills
• Good level of spoken and written English
• Performance Driven
• Customer focus
• Networking acumen 
• Cross-functionality
• Precision, accuracy, timeliness
• Flexibility and innovation
• Domicile: Milan or Rome

Desirable Skills/Experience

• Prior pharmaceutical industry experience
• Experience of working on cross-functional teams
• Focus on delivery and results
• Develops collaborative working relationships
• Problem solving skills

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

AstraZeneca offers a dynamic environment where you can be at the forefront of medical innovation. We leverage our unique position as medical leaders to shape the future of healthcare, providing opportunities to improve patients' lives while developing your career. Our collaborative culture fosters partnerships with thought leaders, policy makers, and patient groups, driving meaningful change through science.

Ready to make a difference? Apply now to join our team!