Q. Where do you currently work?
A. I work for Halozyme Therapeutics, a biopharmaceutical company based in San Diego, California, specializing in endocrinology, oncology and dermatology products. It's a small company with about 140 people. When l started five years ago l was employee 21. The company has grown considerably since.
Q. What is your role at Halozyme Therapeutics
A. I am the Associate Director for Regulatory Affairs & Quality Assurance (QA). Even though my job title includes QA, my role has evolved primarily into a Regulatory Affairs role so l don't perform any of the quality assurance activities anymore. I am responsible for the regulatory affairs functions for investigational products in the dermatology area. I work closely with research & development, product development and clinical development to ensure there is an effective linkage of regulatory strategy and regulatory requirements so submissions and approvals of regulatory filings are delivered in a timely manner.
Q. What is a typical day like for you on the job?
A. My day varies, l participate in project team meetings, work on regulatory strategy and systems, review documents such as clinical trial reports and plans, and work on submissions to the FDA/EMA (Federal Drug Administration/European Medicines Agency). There are a lot of meetings, co-ordination and implementation involved. I collaborate with many departments and work with project managers to co-ordinate meetings and provide information to regulatory agencies. In my current project, l serve as the regulatory lead for Halozyme's alliance partner, Baxter Bioscience.
Q. What skills are necessary to be successful in your job?
A.
Being organized is very important. You must also be able to handle working on many tasks at one time and have great communication skills both oral and written. I also think that a science background is essential to helping you establish credibility with other departments in order to talk their language.
Q. What do you like most about what you do?
A. I enjoy interpreting regulations. There is a lot of "gray" in regulations which makes things fun and provides you with flexibility in your strategy and your submissions to best position the company for FDA approval. I love this strategic side of regulatory affairs. You need to really plan ahead and know what moves you will make; it's kind of like a game of chess.
Q. How did you end up working at Halozyme Therapeutics?
A. I was looking to get into a quality assurance/regulatory affairs role in the pharmaceutical industry. While at CP Kelco, formerly Kelco Biopolymers, a division of Pharmacia/Monsanto, doing regulatory affairs and quality assurance l decided to purse my Masters in Regulatory Affairs at San Diego State University. For my Master's thesis l did a comparison of IND (Investigational New Drug) and IDE (Investigational Device Exemption) applications. The subject of my thesis filled in some of the gaps in my background and allowed me to transition from bulk excipients/food additives to pharmaceuticals. It is what tipped the scale for me to receive a job offer from Halozyme.
Q. Why did you choose to go into Regulatory Affairs?
A. I really enjoy interacting with regulatory agencies and you don't get to do this in quality assurance. Regulatory Affairs is also a lot more strategic in nature.
Q. What is your educational background?
A. I have a Bachelor of Science in Textile Science, a Bachelor of Science in Chemistry and Master of Science in Analytical Chemistry from Purdue University. I also have a Master of Science in Regulatory Affairs from San Diego State University.
Q. How did your education play a role in where you are now?
A. I wanted to take a program where l could build upon my job experiences and where the degree would be recognized outside the local area.I opted to take SDSU's Masters in Regulatory Affairs programs for this reason over the Regulatory Affairs certificate program that was available. This really helped me to hit the ground running in my current job.
Q. What are your near-term and long-term career goals?
A. l would like to continue to work in the regulatory affairs area and expand my responsibility into different therapeutic areas.
Q. What advice would you give to students and professionals currently in the life sciences industry considering a career in Regulatory Affairs?
A. No matter what job you have, learn as much as you can. There is something to learn in every job. Sometimes people forget this because they are too focused on their next career move. If you have this kind of attitude it can really limit you. You also need to be very realistic about what your job prospects are based on your capabilities. If you want to get into regulatory affairs, l would encourage you to get into a company and get involved in regulatory submissions at any level. It doesn't have to be in a regulatory affairs role specifically, you can do it in other departments like R&D to get some experience.
Q. Is there anything else you would like to mention?
A. If you are interested in a career in regulatory affairs, you will find it easier to transition into this area if you come from an R&D, clinical or quality assurance background since you will interface with all of these departments and the regulatory affairs professional is expected to have some understanding of all these different areas.
Field: Regulatory Affairs
Job: Associate Director, Regulatory Affairs & Quality Assurance
Company: Halozyme Therapeutics
