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Global Regulatory Compliance Associate

2 mesi fa

Milano, Lombardia, Italia Meet Recruitment Limited A tempo pieno
Job Description

We are seeking a highly skilled Regulatory Affairs Associate to join our team at Meet Recruitment Limited.

Key Responsibilities:

  • Assist in the preparation and submission of regulatory documents to regulatory agencies, ensuring compliance with applicable regulations and standards.
  • Prepare submissions of licence variations, notifications, and renewals to strict deadlines, monitoring and setting timelines for approvals.
  • Ensure compliance with regulatory requirements and guidelines, monitoring and updating regulatory documentation as necessary.
  • Participate in meetings with regulatory agencies and manufacturers as needed, advising on regulatory requirements.
  • Document and track regulatory submissions and regulatory authority approvals.
  • Review, proofread, and approve artwork of packaging materials to ensure compliance with regulatory requirements.
  • Prepare Summary of Product Characteristics, Patient Information Leaflets, and labelling according to the Quality Review Documents (QRD) format.
  • Provide ongoing regulatory support to the Regulatory Affairs Manager(s) and project teams to ensure regulatory concerns are planned and accounted for.
  • Stay up-to-date with national and international legislation, guidelines, and maintain RA archives electronically.

Requirements:

  • Master's degree in pharmaceutics, health care, life sciences, or related fields.
  • 2+ years of experience in a similar role, preferably in an international environment.
  • Excellent planning and time management skills.
  • Good knowledge of relevant European guidelines, applicable legislation, and regulations.
  • Fluent communication skills in English (written and oral), with Dutch being an asset.
  • Determined, persuasive, assertive, and communicative personality.

Competencies:

  • Strong team player with the ability to work effectively in a team setting and interact with people of different seniority and functional backgrounds.
  • Ability to work independently and as part of a team.
  • Highly ethical, honest, reliable, accountable, and loyal.
  • Ability to handle and enjoy complex and changing environments.
  • Positive 'can do' attitude.
  • Ability to consistently meet deadlines, remain organized, adaptable, and autonomous.
  • Good communication and presentation skills.
  • English language skills (spoken and written), with Dutch being a bonus.
  • Ability to work concurrently on projects with specific instructions that may differ from project to project.