Mihaela Trandafir

Background

About Mihaela Trandafir

I am a Regulatory Affairs Manager at Arriello, a leading provider of global regulatory and safety services for the pharmaceutical industry. With a PhD in Pharmaceutical Chemistry and a Qualified Person certification by National Romanian Agency, I have over 10 years of experience in the pharmaceutical industry, spanning regulatory affairs, quality assurance, and quality control. My core competencies include managing product life cycle management and EU submissions for various clients, ensuring quality and compliance with regulatory requirements and project governance. I have successfully managed multiple LCM submissions, eCTD publishing, readability testing, and artwork updates for different therapeutic areas and markets. I also collaborate and communicate effectively with local and international teams, clients, vendors, and regulatory authorities. Being advanced in French, I can provide support for French-speaking players in the industry. I thrive in a fast-paced and dynamic environment and I am passionate about delivering high-quality work.