LifeBee, is a ProductLife Group Company and leading international strategic and digital consulting firm, supporting Life Science companies in their journey towards digitalization, technological innovation, operational excellence, and proactive compliance. The focus is on the GxP regulated areas of Chemical, Bio-Pharmaceutical, Medical Devices, and Nutraceutical companies, particularly in Production, Quality Assurance, Laboratories, Logistics, Serialization, Industrial Operations, Regulatory Affairs, and Pharmacovigilance.

ProductLife Group (PLG) is a dedicated life sciences outsourcing and consulting company. The group has its HQ in Paris and affiliates around the globe with teams in all key regions: North America, Europe and APAC.

If you are passionate about Digital Transformation and Life Sciences and are looking to kick start your career in this field supporting high-end local and international clients through their journey to Digital Excellence this might be your jam!

Through structured training entailing, on-the-job training and development as well as mentoring, you will drive the success of increasingly complex projects in the Pharmaceutical and Life Sciences world.

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

Responsibilities:

According to your experience and expertise, you will be responsible for increasingly complex activities such as:
  • Advising customers, on the most suitable solutions to their needs;
  • Implementing, customizing, integrating, test and validation of market-leading and cutting-edge software applications for Life Sciences;
  • Planning and executing projects streams, drafting specification, 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 Consultant role familiarity with Life Science Software solution, regulations and guidelines good knowledge of individual productivity tool (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 programming languages (i.e., SQL, Javascript, Python, C#);
  • Knowledge of Industry (preferred in Life Science Market) Software Solution, 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

Senior Consultant- Regulatory Affairs -Italy

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