Daniela Malandruccolo

Background

About Daniela Malandruccolo

I am a strategic Regulatory Affairs leader with over 20 years in the pharmaceutical sector, focusing on various therapeutic disciplines. I pride myself on a natural curiosity that drives me to make things better. Whether it is enhanced value, increased efficiency, continuous improvement or implementation of new ideas, I recognize the benefit of considering diverse perspectives to evolve my contribution to the industry. My “why” is driven by the purpose behind what I do – the ability to contribute to bringing quality lifesaving treatments to the patients who need them. Recently, I was recognized by my current organization, Seagen, with the Impact Award for the integrity, comprehensive support and deep knowledge that I provided for a complex Canadian Clinical Trial Application (CTA). My journey into Regulatory Affairs came about indirectly, fueled initially by my sense of adventure and then by my passion for making a difference for others. After completing a Bachelor’s degree in Molecular Biology from the University of Waterloo, I had the opportunity to work in Bermuda, gaining exposure to a number of areas including the pharmaceutical sector. I was intrigued by pharma and recognized an opportunity to merge my interest in science with business by pursuing the Regulatory Affairs field. This led to my completion of a post-graduate certificate from Humber College and has resulted in a progressive career where I now hold a leadership role. My core areas of experience and expertise include: • Regulatory development and submission strategies; • Project, timeline and life cycle management to guide on complex project expectations; • Compilation and assembly of submission documents; • Strong knowledge of and relationships with Health Canada; • Effective interpretation and application of Canadian and international regulations; • Analytical mindset to consider precedence and provide interpretation to key stakeholders and international counterparts. If you share a common passion for the field of Regulatory Affairs, I would be happy to connect and share knowledge related to our profession. Please feel free to reach out through LinkedIn.