What are your primary job responsibilities?

Regulatory Affairs focuses on drug approvals and post-approval changes with FDA and other global agencies. I am focused on Module 3 of the Regulatory filing-Chemistry, Manufacturing and Controls. This means what the drug is, who manufactures it, how it is manufactured, what materials go into it, and how it is tested and packaged. I evaluate regulatory changes and oversee the change strategy, including timing and content of the filing. 

What is a typical work day-in-your-life like?

Lots of cross functional meetings, providing regulatory advice, discussing strategy and executing regulatory filings. 

How did you find your first job?

Through recommendations from my awesome advisor!

What level of education (Bachelor's, Masters, PhD, etc.) is required to do your job? 

We really see a varied level in Regulatory Affairs, minimum of a Bachelors but our industry has Masters, PhDs and PharmDs as well

What is your work schedule like? Do you ever work weekends or nights?

Usually 9-5 type job, but can have earlier or later meetings if you're working with colleagues or regulatory agencies globally

Do you travel for work? If so, in what capacity, and how often?

Not currently, but sometimes travel is needed to manufacturing sites, regulatory conferences or meetings with regulatory authorities, such as FDA

What is your work environment like? Do you work mostly with a team or mostly independently? Do you stand, sit, or move most of the day?

Work with a team! So much cross functional interaction! I sit most of the day

What do you like most about your job?

The variety of challenges and how broad the scope is-the work is never boring

What are some tools or skills that you can't live without? These can be technologies, soft skills, hardware, or anything else you can think of.

Communication skills are super important because you're depending on your subject matter experts. You need to like reading and writing, keep up to date with regulations and have critical thinking skills. Being able to quickly identify risks is also important. 

What skills, traits, talents do you have that you think make you a good fit for your job?

Strong compliance mindset and commitment to problem solving

What's your best productivity trick?

Break up your work!

Do you have any habits that are essential to your professional success that you wish you started earlier?

I wish I knew more about general business earlier

What's the best career advice you've ever received? What career advice would you give to someone starting out in your field?

Best advice-make my writing sharper and easily digestible. For people starting out, I'd recommend to diversity skill set as much as possible.

How do you build community in your career field? Are you part of any professional organizations?

Right now I'm involved in Regulatory Affairs Professional Society and Healthcare Business Women's Association

Do you have a favorite memory from your time at the University of Minnesota?

I loved my undergraduate research experience