How did you get into regulatory affairs?
The simple answer is, "from the ground up". When my passion for a career in biotechnology became clear, I reached out to anyone and everyone in my network who could potentially shed light on the industry. It took an extensive series of informational interviews to open my eyes to the field of regulatory affairs back in 1999. Based on my interests in novel science, medicine, strategy and teamwork, it became increasingly apparent that working in regulatory affairs had the potential to be a wonderful fit. I set out to obtain an entry level role in the field, which proved difficult to secure; it took much energy, application and patience.
I worked temporary and contract jobs across just about every field in the industry until I was finally offered a contract role to support an IND filing in regulatory affairs at InterMune, Inc. (a small company focused on orphan medicines in the San Francisco Bay Area). My initial role was copyediting a new US Investigational New Drug application (as well as literally making copies of every volume of the paper IND). I worked long hours, learning as much as I possibly could from the many experienced mentors in the RA department and within the company, and gradually secured a full-time entry-level role as a Regulatory Affairs Associate.
What is your current role?
I am currently a Senior Director of Regulatory Affairs at Ultragenyx Pharmaceutical, a small company that transforms good science into great medicine for rare genetic diseases.
What challenges/opportunities did you face advancing up the career ladder?
The challenges inherent in advancement include: growing from a technical expert into a skilled manager and mentor, and adapting effectively to change and gaining a balance between career and family. I am grateful to have worked for wonderful companies throughout my career, though some grew too quickly, downsized, and/or significantly reorganised — all of which can result in a variety of emotions and tensions across teams as they settle into new responsibilities and roles. Some of the opportunities that have always come with change, in my experience, are the openings for self-growth/learning and new prospects to both add value and strengthen connections within an evolving organisation and industry.
What does diversity mean to you as a regulatory affairs professional?
Diversity to me is more than simply equality across races, cultures, genders; it is bringing a range of different backgrounds and ideas together in order to strengthen a working team or organisation.
What tips do you have about utilising diversity to improve business performance? How can focusing on diversity impact business outcomes?
A well-diversified team is better able to flex in their roles, understand differences of opinion or perspective, and to effectively use these differences as assets. Building a culture that embraces comfortably challenging each other and allowing freedom in thinking and speaking can ultimately result in a competitive edge – during brainstorming, strategic product development, recruitment and retention of personnel, commercial activities, and in preparing for diverse agency interactions.