Senior Consultant- Regulatory Affairs -Italy

Senior Consultant- Regulatory Affairs -Italy

We are currently looking for Consultants at different levels to join our Regulatory Affairs Teams.

According to your experience and expertise, you will be responsible for increasingly complex activities such as:

Responsibilities:

• Advising customers on the most suitable solutions to their needs;
• Implementing, customizing, integrating, testing and validating market‑leading and cutting‑edge software applications for Life Sciences;
• Planning and executing project streams, drafting specifications, tests and validation technical documentation;
• Enhancing collaboration with local and global software vendors;
• Providing qualified technical and functional support and training;
• Aiding customers in technical validation activities

Experience:

• STEM degree (i.e., computer science, computer engineering, biomedical engineering, statistics, mathematics, physics);
• 2 or more years’ experience in a Consultant role familiarity with Life Science Software solution, regulations and guidelines, good knowledge of individual productivity tools (MS Office)
• Knowledge of Life Sciences Software solutions, regulations and guidelines
• Analytical and problem‑solving approach
• Fluency in Italian and English is required.

Nice to have:

• Knowledge of Industry (preferred in Life Science Market) Software Solutions, particularly in RIMs , QMS, MES/EBR, BPM, LIMS, Workflow Management, Document Management, Business Analytics, Machine Learning, Artificial Intelligence,
• Knowledge of Regulatory software solutions such as Veeva RIMS (modules: Submissions, Submissions Archive & Registrations), Extedo RIMS ("Pulse"), Aris Global RIMS, Ennov