Regulatory Affairs Specialist

4 settimane fa


Roma, Lazio, Italia Meditrial Europe Ltd. A tempo pieno
Job Title: Regulatory Affairs Manager

Meditrial Europe Ltd. is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our regulatory affairs team, you will be responsible for overseeing the regulation process for products requiring governmental approval, including filing necessary applications and handling all government interactions.

Key Responsibilities:

  • Management of CTD (Electronic Common Technical Document)
  • Collaboration during implementations of regulatory strategies for New MA through National/Decentralized/Centralized Procedures
  • Preparing submissions of variations type I, II, Renewals, and Safety variations
  • Management of CMC activities (updating module III of ECTD)
  • Collaboration during the Management of Recall
  • Creation and updates of Technical File (TF)
  • Relationship with manufacturer and interface with all pharmaceuticals database
  • Review and submission of promotional materials
  • Support the management of clinical investigations
  • Management of Medical Device Post-marketing and Surveillance Medical Devices activities
  • Notification of new Food Supplements and any changes to Ministry of Health
  • Supervision of International Regulatory and Quality activities

Requirements:

  • Master's Degree in science or related field, Doctor of Medicine MD is a plus
  • Thorough experience in life-science field and Regulatory Affairs
  • Proficiency in oral and written English and Italian (third language is a plus)
  • Proficient in Microsoft Office (MS Outlook, MS Word, MS Excel, Ms Power Point)
  • Excellent communication, planning, and organizational skills
  • Demonstrated ability to handle multiple competing priorities


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