Meet Mihaela Trandafir
Regulatory Affairs Manager at Arriello
Mihaela holds a PhD in Pharmaceutical Sciences from the University of Bucharest, Romania, and further broadened her academic experience through a one-year study program in France during her pharmaceutical studies.
She began her career as a trainee in the Quality Assurance department at a large pharmaceutical manufacturing site, later moving into Quality Control. It was during this time that she discovered Regulatory Affairs – a field where her expertise and interests came together naturally.
Mihaela brings experience from both manufacturing environments and consultancy roles, giving her a well-rounded perspective on product development, quality processes, and the journey of medicines from production to market.
Mihaela has been with Arriello since 2019, where her primary focus is regulatory lifecycle management. She supports clients throughout the full regulatory process, including engaging with National Competent Authorities (NCAs) and ensuring that local requirements are effectively incorporated into submission strategies, helping products meet market-specific expectations.
In addition to her core responsibilities, she was also involved in activities such as Readability User Testing and Third-Party Management.
Just recently, Mihaela has been voted the Company Employee of the Quarter from her colleagues.
Can you tell us about a day in the life of a Regulatory Affairs Manager?
At Arriello, my role as a Regulatory Affairs Manager combines regulatory expertise with project coordination across different client projects. Depending on the project scope and client needs, I contribute both as a technical regulatory professional and as a project manager – ensuring smooth collaboration and efficient delivery of services.
My day-to-day activities involve close communication with clients regarding the regulatory support we provide, including local submissions, regulatory intelligence, and consultancy services. I also work closely with local partners and stakeholders to coordinate project activities across different markets and support the successful execution of regulatory strategies.
In addition to providing technical support for regulatory activities, I oversee project timelines, priorities, forecasting, budgeting, and invoicing activities to help ensure that projects are delivered efficiently, compliantly, and to a high standard of quality. The role also involves monitoring project progress, coordinating resources, and maintaining transparent communication between all parties involved.
As part of one client collaboration, I also function as an integrated member of the client’s team, providing ongoing support for regulatory activities within their Regulatory Information Management (RIM) system. This experience offers valuable insight into client processes and strengthens the partnership through day-to-day operational support and close collaboration.
What makes the role particularly rewarding is the dynamic nature of the work — balancing technical problem-solving, client interaction, and cross-functional coordination in an evolving regulatory environment.
What do you like best about collaborating with clients?
What I value most about collaborating with clients is the opportunity to become a trusted extension of their team, leveraging my technical expertise to provide operational relief during critical periods. Thanks to my background in the manufacturing industry, combined with more recent consultancy experience, I can quickly adapt to different organizational structures, processes, and ways of working.
This allows me to provide clients with fast yet professional onboarding experience and to efficiently integrate into their teams, particularly during periods of increased regulatory activity or temporary resource gaps. I enjoy bringing flexibility to each collaboration, tailoring my expertise, and approaching the specific needs of the client while maintaining a strong focus on quality, communication, and practical solutions.
What is the current trend you see in the industry and how does it impact our clients and patients?
A key trend I see in the pharmaceutical industry is the growing integration of artificial intelligence into regulatory and drug development processes. As a pharmacist, I naturally prioritize patient safety, medicine availability, and ensuring product quality and efficacy.
At the same time, the regulatory landscape is continuously evolving to keep pace with scientific innovation and patient needs. AI is increasingly being adopted in regulatory lifecycle management – for example, in submission preparation, gap analysis, and drafting responses to deficiency letters.
This shift has a meaningful impact on both clients and patients. For organizations, it improves efficiency, reduces time to submission, and supports more consistent, high-quality documentation. For patients, this can translate into faster access to safe and effective medicines, without compromising regulatory standards.
Importantly, by automating repetitive tasks, AI allows regulatory professionals to focus more on strategic decision-making and maintaining the overall quality and compliance of products, ultimately supporting better patient outcomes.
What is unique about working for Arriello?
Being with Arriello for almost seven years, I can genuinely say that the experience is unique. One of the aspects that stands out most is the strong sense of collaboration across international teams. We collaborate closely with colleagues from different countries and locations, yet the experience feels seamless – as though we are all part of the same team, working side by side toward shared goals. That collaborative culture is something I truly value and believe makes Arriello unique.
Another defining aspect is the wide range of opportunities the role offers. Some projects provide highly technical regulatory experience, allowing you to deepen your expertise and take on new regulatory challenges. Others offer the opportunity to work as an integrated member of a client’s own team, gaining insight into their systems, procedures, and ways of working. In addition, collaboration with local partners brings further learning opportunities and exposure to different perspectives, making the experience both dynamic and professionally rewarding.
