QA Regulatory Junior Specialist Maternity Leave

Posté 08 nov. 2023

Modugno, Bari - Italy

Demander un identifiant 269489


Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.


Your role: 


You will manage duties and activities assigned to by proper supervisor, GRA CMC (Global Regulatory CMC) or Company's Regulatory Affiliates as per following task or activities: coordinate and prepare in due dates regulatory related documents, certificates, statements, legalization of documentation for product renewals, etc; ensure review and availability of Site Master File (SMF) for any regulatory submission; provision of Site GMP certificates, Manufacturing Authorization License and CPPs (Certificates of Pharmaceutical Product) for submission or renewal; follow up and prepare submission documentation needed for variation to Local Health Authority (AIFA).  


Who you are: 


  • Degree in Scientific-related disciplines; Pharmacy, Pharmaceutical Chemistry and Technology, Chemistry, Biology, etc.
  • Experience with Site Master File (SMF) 
  • Experience with notification to AIFA on human serum albumin import-export 
  • Experience with change management related to the facility changes 
  • Fluent and written in English and Italian 

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!