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Regulatory Affairs Specialist

2 mesi fa

Roma, Lazio, Italia Meditrial Europe Ltd. A tempo pieno
Job Description

Meditrial Europe Ltd. is a leading clinical research organization dedicated to delivering unparalleled outcomes for innovators in the life science industry. As a Regulatory Affairs Manager, you will play a crucial role in ensuring compliance with regulatory requirements for products requiring governmental approval.

Key Responsibilities:
  • Manage the regulation process for products, including filing necessary applications and handling government interactions.
  • Develop and implement strategic regulatory strategies for multiple projects in collaboration with subject matter experts.
  • Coordinate inspections of the organization and contract facilities, and develop procedures to ensure regulatory compliance pre and post-market.
  • Prepare and submit regulatory documents, including CTD (Electronic Common Technical Document) and variations.
  • Manage CMC (Chemistry, Manufacturing, and Controls) activities and collaborate on the creation and updates of the Technical File.
  • Interface with manufacturers and pharmaceutical databases, and review and submit promotional materials.
  • Support the management of clinical investigations and medical device post-marketing and surveillance activities.
Requirements:
  • Master's Degree in a science-related field or Doctor of Medicine (MD).
  • Thorough experience in the 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 PowerPoint).
  • Excellent communication, planning, and organizational skills.
  • Demonstrated ability to handle multiple competing priorities.