Regulatory Affairs Manager

RAM

Join our global team as a Regulatory Affairs Manager.

Regulatory Affairs Manager is responsible for assigned projects and related tasks, applications and dossiers submissions, communication with clients and national authorities.

Position is in Romania (Bucharest).

 

Responsibilities:

  • Manage registration related activities mainly for Romania and EU
  • Compile and submit applications for registration, renewals, variations in accordance with the national and EU legislation
  • Maintain contact with regulatory authorities, client representative
  • Ensure the regulatory compliance of the products in the assigned portfolio
  • Preparation, review and approval of artworks
  • Work cross-functionally with central and local teams
  • Participate in audits
  • Translate/update the specific product dossier documents
  • Regular monitoring of local law and NHA requirements (Regulatory Intelligence)
  • Review and regulatory approval of promotional and non-promotional materials, claims
  • Actively interact and provide information, support and advice to internal departments/affiliates and clients on technical and regulatory issues concerning registration or post-approval change documents

Requirements:

  • University degree in Life Science field
  • Fluent English language
  • 3-5 years’ experience in Regulatory Affairs with medicinal products
  • Experience with medical devices, food supplements and cosmetics is advantage
  • Time management skills
  • Ability to solve problems and make decisions

Benefits:

  • Bonus system
  • Remote work
  • International team spirit
  • Personal and professional development
  • Career opportunities
Job Category: Regulatory Affairs
Job Type: Full Time
Job Location: Romania
Job Specification: R2

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