Junior Regulatory Affairs Specialist

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7gyjcw

Are you ready to turn rigorous regulatory craft into faster patient access and real-world impact? In this role, you will help transform cutting-edge science into approved medicines by ensuring timely, high-quality submissions and compliant product maintenance. You will be a core partner to our Regulatory Affairs Manager, working across multiple therapy areas and collaborating closely with medical, quality, supply, and commercial teams—often alongside oncology colleagues as we bring an expanding pipeline to patients. From day one, you will be hands-on with regulatory files, variations, and compliance reviews that keep our medicines available and our standards uncompromising. Your attention to detail and proactive communication will reduce risk, accelerate approvals, and ensure audit readiness. Can you see yourself becoming the go-to partner for robust dossiers, smooth variations, and clean inspections? **Accountabilities** Working closely with the Regulatory team, you will be involved in the following activities:
**Regulatory submissions and lifecycle management**: Prepare, compile, and support submission of high-quality regulatory dossiers; track approvals and commitments to maintain uninterrupted product supply and compliance. **Variation management and change control**: Coordinate variation approvals and implement regulatory changes efficiently, safeguarding timelines, product quality, and market continuity. **Promotional materials oversight**:Review materials from a regulatory perspective to uphold local legislation and internal standards, protecting both patients and company reputation. **Data and archive integrity**: Maintain complete, accurate regulatory archives and databases for transparent traceability, fast responses to authority queries, and audit readiness. **Cross-functional collaboration**:



Partner with medical, quality, supply, and commercial colleagues to align regulatory plans with launch, maintenance, and safety objectives; anticipate risks and drive timely resolution. **Continuous improvement and inspection readiness**: Standardize ways of working, close gaps proactively, and contribute to a culture of learning—supporting smooth inspections and sustained excellence. **Essential Skills/Experience**: - Supporting the Regulatory Affairs Manager to all activities related to the registration and maintenance of products in compliance with all local and global codes, standards and procedures
- 1 year of professional experience in Regulatory Affairs within a pharmaceutical company or health care authority
- Assisting with regulatory file compilation and submissions, regulatory approval and maintenance procedures including maintenance of regulatory databases
- Supporting the Regulatory Affairs Manager for all the activities concerning the variations approval process and the implementation of the regulatory activities established by the law and by AstraZeneca
- Maintaining regulatory/technical archive of product and tracking of submission/achievements being able to satisfy the requirements of any audit or inspection
- Supporting the Regulatory Affairs Manager to the review of promotional materials, from a regulatory point of view,



to guarantee the compliance with local legislation and MC Code/SOPs
- Manage all activities and Account relationship according with Company Values, Code of Conduct, Guidelines/Internal procedures and Italian legislation **Desirable Skills/Experience**: - Degree in Pharmacy, Life Sciences, or a related field
- Working knowledge of EU and Italian regulatory requirements for medicinal products
- Experience with regulatory information management and document management systems
- Strong communication skills in Italian and English, written and verbal
- Proven ability to prioritize multiple dossiers and deadlines with high attention to detail
- Stakeholder management skills and collaborative approach across medical, quality, supply, and commercial functions 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. **Why AstraZeneca**:
Here, your regulatory expertise directly helps deliver life-changing medicines sooner, supported by colleagues who combine scientific depth with agile execution. You will work at speed with cross-functional partners—bringing regulatory, clinical, and commercial minds together to solve access challenges and scale what works. We value ambition alongside kindness and empower you with autonomy, modern tools, and shared learnings across therapy areas, including oncology, so you can grow your skills and shape outcomes that m

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7gyjcw