• Clinical Regulatory Affairs Manager Romania
  • Arsis Global in Romania, , Romania
  • jobs
  • 2 weeks ago

jobs description

Arsis Global is a CEE based talent matchmaker for business professionals and leading businesses to drive breakthrough performance and provide efficient solutions for future challenges. Our goal is to connect talents like you to premier companies in a wide variety of industries and regions to push the boundaries and achieve the extraordinary.


LOCATION: Bucharest, Romania

INDUSTRY: pharmaceutical

• Strategy Development: Lead regulatory strategy throughout clinical development.
• Application Management: Coordinate applications to Regulatory Authorities (CTAs/INDs, orphan designations, etc.).
• Compliance Assurance: Ensure regulatory document compliance for submissions to Authorities and Ethics Committees.
• Stakeholder Engagement: Represent Global Regulatory Affairs, provide insights in project meetings.
• Leadership and Training: Supervise specialists, aid their development, contribute to strategy, and offer guidance.

•... Bachelor and/or Master in a scientific or healthcare field
• Minimum 5 years of regulatory affaird experience in clinical resarch, biotech or pharma (inc clinical submissions)
• In depth knowledge of drug development process, regulatory milestones, and specialized EU/US regulatory activities.
• Ability to interpret clinical/pre-clinical study results, familiarity with trial methodology, strong grasp of pharmaceutical regulations.
• Willingness to travel domestically and internationally, including overnight stay
• Proficient MS Office/ Office 365
• Fluent Romanian and English

If you are looking for a new challenge or a position with freedom to apply your knowledge and skills, please register with your CV, preferable in English


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