Regulatory Affairs Specialist

2 settimane fa


Roma, Lazio, Italia Meditrial Europe Ltd. A tempo pieno
Regulatory Affairs Manager - Pharma/Medtech

Meditrial Europe Ltd. is a leading clinical research organization dedicated to delivering unparalleled outcomes for innovators in the lifescience industry.

As a Regulatory Affairs Manager, you will oversee the regulation process for products requiring governmental approval, including filing necessary applications and handling all government interactions.

The position will support and/or drive strategic regulatory strategies for multiple projects together with subject matter experts.

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 manufacturers
  • Interface with pharmaceutical databases
  • Review and submission of promotional materials
  • Support of clinical investigations
  • Management of Medical Device Post-marketing and Surveillance Medical Devices activities
  • Notification of new Food Supplements and 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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