In this article, we shine the spotlight on Dr Tatiana Reimer, Principal Consultant at NDA.


A commitment to quality of life and patient well-being

Dr Tatiana Reimer, Principal Consultant at NDA, is a dedicated expert who understands that behind every manufacturing process is the goal of helping patients live healthier, fuller lives. Guided by her passion, she works to help clients navigate complex regulatory requirements and ensure new therapies can deliver on their life-changing promise as efficiently as possible.

Tatiana's academic journey began with a focus on biology, which ultimately led her to earn a Ph.D. in Cellular Biology. During her research training, Tatiana spent most of her time in the laboratory conducting experiments. As she contemplated her career path, she felt the urge to shift from scientific research to more applied avenues, prompting a significant transition into the pharmaceutical sector. Guided by her mentor, Tatiana gained valuable experience in clinical development and regulatory affairs. She was immediately drawn to regulatory affairs, making her pursue further education in the field. “I think moving to the field of regulatory affairs was inspired by my desire to put my scientific background into practice. I see regulatory affairs as a space where scientific knowledge can be strategically implemented to develop successful programs. For me, regulatory affairs means using my scientific expertise to make an impact that aligns with my values and career goals,” Tatiana says.

Tatiana started her career at a small biotech firm where she was involved in the development of an orphan drug. Subsequently, she joined the European Medicine Agency as a paediatric coordinator. For the next 12 years, she worked for a major pharmaceutical company initially as an international regulatory manager and later ascending to the position of global CMC regulatory manager. Her passion led her to the field of biologics, where she spent the following five years supporting major filings and life cycle management of important biopharmaceutical products. It was in this role that she discovered her niche in regulatory strategy, paving the way for her transition to the areas of haematology, oncology, and rare diseases. She later moved from industry to consulting.

Reflecting on her career, Tatiana shared,

“I find it fascinating that my career has followed a regulatory pathway. I enjoy it because it’s such a diverse and dynamic environment where staying updated and enhancing your knowledge is essential. I consider myself fortunate to have worked on high-impact projects and experienced all phases of development.”

Throughout her journey, Tatiana had the privilege of being mentored by exceptional leaders in the field of regulatory affairs. This support not only helped her develop her expertise but also encouraged her to approach her work from a patient perspective, always looking for opportunities on a global scale.

A unique perspective

Tatiana’s passion for cell and gene therapies and CMC stems from a deep fascination with the innovative potential of biotechnology. She is captivated by the advancements in therapeutic areas, particularly cell and gene therapies, and sees these therapies as tools that can genuinely improve the quality of life of patients.

Tatiana’s background in CMC provides her with a unique perspective of understanding the processes involved in ensuring the safety and efficacy of manufacturing and testing these therapies. She found her calling in contributing to the development of this therapeutic area that pushes the boundaries of science and holds the promise of transforming lives for the better.

“I always try to see things from the patient perspective. I ask myself what is important for the patients and how their quality of life can be improved. That is why I have a passion for cell and gene therapies because those transformative therapies often make a difference in the lives of patients and their families. I think it is so important for everyone to enjoy life with their families, including those with rare, genetic diseases.”

Embracing knowledge and innovation

Tatiana performs a range of responsibilities in her role as Principal Consultant at NDA. As a project manager, she defines project scopes and identifies the right talent to work with on the project. She also maintains client relationships by following up on completed projects and exploring potential collaborations. As a principal consultant, Tatiana uses her vast knowledge in CMC and cell and gene therapies to create development plans and gap analyses for clients in early clinical trial phases.

Tatiana’s decision to join NDA was driven by a combination of personal and professional choices that resonated with her career aspirations.

“My decision to join NDA was motivated by my desire to work alongside inspiring leaders. Having collaborated with a few of them in the past, I admired their expertise and leadership qualities. NDA’s team of experts combine science and regulatory expertise in a unique way, being a perfect fit from my personal perspective.”  

NDA also has a strong culture of collaboration and teamwork. I initially had my concerns about working from home, but the collaborative environment created by my colleagues bridges the physical distance. These values make NDA the ideal place for me to grow in my career.”

Tatiana enjoys her interactions with NDA clients and adopts a thoughtful approach when collaborating with them.

“What intrigues me the most about working with clients, particularly small biotech, is their innovative spirit. Their unique approaches and questions provide great insights to therapeutic development. When working with clients, I take the time to genuinely understand their priorities, needs, and expectations. Instead of rushing into discussions, I think it is best to keep an open mind and engage in thorough conversations to understand a client’s vision and challenges. I listen carefully to what they are saying and try to ask relevant questions. My goal is not to overwhelm them with a ready-made solution but to tailor the solutions to their specific needs. A unique approach is a foundation for a lasting partnership.”

About

Dr Tatiana Reimer

Principal Consultant

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