At Asphalion, our success is driven by the dedicated and passionate individuals who make up our incredible team. Today, we wanted to highlight and share the Asphalion journey of Beatriz Aldaz, CMC, Biotech, Scientific & Regulatory Affairs Senior Consultant on our “People Talks”.
“I joined Asphalion four years ago as a Life-Cycle Management (LCM) Regulatory Affairs Senior Officer. Since then, Asphalion has offered me the flexibility to explore internal opportunities, transitioning from LCM to CMC (Chemistry, Manufacturing, and Controls) department and focusing on biological products—my primary goal since moving from academic molecular oncology research to industry regulatory affairs nearly a decade ago.
I am especially grateful to Asphalion for supporting my growth, allowing me to move up two positions to my current role as Scientific and Regulatory Affairs Senior Consultant. This progression demonstrates how Asphalion values its employees, recognizing and rewarding their efforts, dedication and experience. Also, I would like to remark tha during a brief departure from the company, Asphalion welcomed me back with open arms when my transition proved unsatisfactory. For that, I am deeply grateful, and it reinforces my belief in the company’s commitment to its people.
At Asphalion, I am involved in the creation of quality documentation for dossier submissions both in US and Europe at different stages of the product life-cycle, from investigational products in clinical development phases to products requesting regulatory marketing authorisation and quality changes post-authorisation. I work with a wide range of complex products, such as oligonucleotides, recombinant proteins, biosimilar and radiolabelled antibodies, vaccines and advanced therapies (cellular, tissue engineered and gene) medicinal products. In addition to other services, my consultancy role extends to assisting clients throughout the development process of new medicinal products. This encompasses preparing Scientific Advice Meetings with regulatory bodies and conducting Regulatory GAP analyses to help clients discern the most effective route for their product’s market entry.
In my daily work, I collaborate with skilled professionals from diverse sectors of biomedicine, including start-ups and established firms. These interactions enrich my career development by providing a broad and dynamic perspective on product development. Additionally, my ongoing collaborations with experts within my division and across other departments at Asphalion greatly enhance my learning experience. Their professionalism and passion make every project both rewarding and enjoyable.
Moreover, working at Asphalion provides the intellectual challenges that keep me motivated and drive my personal and professional growth. Collaborating with diverse products, clients, and development stages means I’m always learning and engaging in meaningful exchanges with my peers. On top of that, the working environment is excellent. Even if your team is located elsewhere, we always make time to bond and have a nice time, which I really appreciate.”
Stay tuned for more insights about the talented professionals who make Asphalion what it is today!
Fancy joining us? Have a look here at our careers’ opportunities: https://careers.asphalion.com/
