Regulatory Affairs Specialist (L.68/99)

AstraZeneca; Milano; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A leading biopharmaceutical company is seeking a Regulatory Affairs Specialist in Milan. This role involves ensuring compliance with regulatory authorizations, managing product applications, and collaborating with cross-functional teams. The ideal candidate has a degree in science and strong knowledge of EU pharmaceutical legislation. Join us to impact patient lives through medical innovation in a dynamic workspace.

Competenze

• University degree in a relevant field.
• Good knowledge of national and EU pharmaceutical regulations.
• Proficient in both spoken and written English.

Mansioni

• Support registration applications for new products and indications.
• Maintain compliance for registered products.
• Interact with Italian Regulatory Authorities on product issues.
• Review promotional materials for compliance.
• Engage in competitive intelligence activities.

Conoscenze

Good knowledge of National and EU pharmaceutical legislation

Good written and verbal communication skills

Good level of spoken and written English

Performance Driven

Customer focus

Formazione

University Degree in Science or related discipline

Descrizione del lavoro

Are you ready to make a difference in the world of healthcare? As a Regulatory Affairs Specialist within the Italian Marketing Company, you'll play a crucial role in achieving and maintaining regulatory authorizations for new and existing products. You'll support the Head of Regulatory Affairs & Medical Compliance Lead Nominated Signatory GRP Lead, ensuring compliance with local legislation and SOPs. Your work will guarantee adherence to GRP, Local and Global SOPs, MC Regulatory Process, Quality Manual, and Italian and European regulations. Dive into daily activities that align with the MC Regulatory Process and Quality Manual.

Accountabilities

• Support the Head of Regulatory Affairs & Medical Compliance Lead Nominated Signatory GRP Lead during registration applications for new products, new indications, and extensions, ensuring compliance with national and EU legislation within agreed deadlines.
• Guarantee the correct maintenance of registered products, including renewals, quality and safety updates, and labelling requirements, under the supervision of the Head of Regulatory Affairs & Medical Compliance Lead Nominated Signatory GRP Lead.
• Interact with Italian Regulatory Authorities to resolve product-related issues, maximizing regulatory authorization effectiveness with Line Manager support if necessary.
• Review promotional materials from a regulatory perspective to ensure compliance with local legislation and MC Code/SOPs.
• Engage in competitive intelligence activities.
• Manage special projects (e.g., MA transfer) with support from the Head of Regulatory Affairs & Medical Compliance Lead Nominated Signatory GRP Lead.
• Support the Head of Regulatory Affairs & Medical Compliance Lead Nominated Signatory GRP Lead in maintaining compliance with GRP.
• Manage all activities and account relationships according to Company Values, Code of Conduct, Guidelines/Internal procedures, and Italian legislation.

Essential Skills/Experience

• University Degree in Science or related discipline
• Good knowledge of National and EU pharmaceutical legislation
• Good written and verbal communication skills
• Good level of spoken and written English
• Performance Driven
• Customer focus

Desirable Skills/Experience

• Experience of working on cross-functional teams
• Prior pharmaceutical industry experience
• At least 2 years’ experience in an area of regulatory affairs

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 an environment where you can be at the forefront of medical innovation. With our industry-leading BioPharmaceuticals team, you'll have the opportunity to make a significant impact on patients' lives through our diverse pipeline. We are committed to evolving and accelerating our efforts in various therapeutic areas, addressing unmet needs with groundbreaking solutions. Our collaborative culture fosters growth and development, allowing you to thrive in a fast-paced setting that values creativity and innovation.

Ready to take on this exciting challenge? Apply now and become part of our dynamic team!

Date Posted

28-nov-2025

Closing Date

12-dic-2025

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.