Local Regualtory Affairs Specialist in Romania (Freelance/ 0.1 FTE)

3 hours, 3 minutes ago
Part-time
Junior
Legal
Biomapas

Biomapas

Biomapas offers comprehensive solutions in clinical research, regulatory affairs, pharmacovigilance, and medical information, providing essential support throughout the clinical trial process to enhance drug development and ensure compliance.

Biotechnology
251-1K
Founded 2001

Description

  • Act as the Local Regulatory Affairs Specialist for Romania and the assigned territory.
  • Oversee and manage local regulatory affairs activities for medicinal products, medical devices, and food supplements.
  • Maintain timely communication with local Competent Authorities.
  • Monitor and report changes in national regulatory requirements.
  • Develop and review regulatory strategies to support market entry, lifecycle planning, and post-approval changes.
  • Prepare regulatory documentation for submission to Competent Authorities.
  • Handle regulatory submissions, including educational materials and local notifications.
  • Review labeling components, promotional materials, and product information for compliance.
  • Translate and proofread regulatory materials as needed.
  • Support clients with strategic and operational regulatory affairs advice and other related tasks.

Requirements

  • A degree in biology, pharmacy, medicine, or another life science field.
  • Fluent written and spoken English and Romanian.
  • At least 2 years of experience in local regulatory affairs activities.
  • Proven experience managing local regulatory affairs activities in Romania for medicinal products, medical devices, and food supplements.
  • Experience preparing local documents and regulatory submissions.
  • Strong knowledge of local and international regulations.
  • High motivation to learn and develop within the team.
  • Ability to work remotely on a part-time basis of approximately 0.1 FTE.

Interested in this position?

Apply directly on the company website

Apply Now

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