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Saraswathy Nochur, Ph.D. is an expert on Regulatory Affairs at Alnylam Pharmaceuticals in Cambridge, MA.

How did you choose your career?How did you end up in an offbeat and unconventional career such as this?Was this an easy or hard process for you? If you struggled, how did you overcome these struggles?

I didn’t really choose this path, it’s more like it evolved. The process wasn’t very difficult because it’s a good match for my skillset and what I had already been doing. I had been working at a small company starting as a project manager in drug device development and helped with straightforward submissions for FDA approval of these devices. I then moved into the drug side of the approval process. I have Ph.D. in Biochemical Engineering, which gave me the breadth of scientific experience that I have used in my career. Working in smaller companies has given me opportunities to stretch beyond my background, and I got involved in different areas of the company, including chemistry, preclinical toxicology, and clinical. I started helping the VP of Regulatory Affairs in writing submissions to the FDA and went to meetings with the FDA. So, after a few years working in biotech as a project manager and in devices, I moved into drug development work from a regulatory standpoint. I didn’t plan this path in advance. In fact, I didn’t even know about this career when I initially went into science.

What kind of training, both formal and informal, did you receive to prepare you for your career? How did you choose what additonal training to pursue and how did you choose where to do it?

For regulatory affairs, it’s not common to be at the Ph.D. level, but it helps a great deal because filing applications to conduct clinical studies and receive FDA approval involves chemistry, biology, pharmacology, and clinical aspects of research. Having a technical background has really helped me to plan, strategize, and submit applications to regulatory authorities.

I grew up in India and moved to the US to attend MIT for graduate school where i did my PhD in Biochemical Engineering. Befpre coming to MIT, i did my Bachelors (Chemistry and Microbiology) and Masters in Microbiology. After receiving my Ph.D., I knew that I didn’t want to work in fundamental research or have an academic career in a research lab, so I joined a small company as a project manager. It’s not uncommon for people to take courses in regulatory affairs. However, I received no formal training as I mostly learned on the job and by keeping abreast of the latest developments in the field. It’s important to have good mentors. There is a professional society, the Regulatory Affairs Professional Society (RAPS), that offers courses and a certification program. Some universities, such as Northeastern University, also offer courses. These courses can be helpful for a person to understand what’s involved in the field before moving into it. However, taking courses doesn’t necessarily make a person a good regulatory affairs professional. You need the skillset to be able to think strategically and communicate effectively both written and oral with different audiences. It’s ideal to have a mentor and learn from experience.

How competitve and/or rigorous was the training for your career?

My Ph.D. program was very competitive, but the rest of my training came with experience. You really can’t tie the two types of training together.

How long did it take you to train? Was it shorter or longer than anticipated? If you had any setbacks, how did you deal with them?

Since I learned on the job, there is not a specific time frame. A person really needs seven–eight years of experience presenting, learning, writing, and interacting with regulatory agencies. It’s a continual learning experience. I didn’t go through a formal ladder to get where I am, but many people do by starting out in more junior regulatory positions, such as an associate, and then going up from there.

What was the process like to apply for your first job after your training was over? Was it easy or difficult? How did you cope with any difficulties? Did that differ from subsequent jobs you’ve had?

My first job was as a project manager in diagnostics. I held various roles at the first company I joined for over ten years, during which I started to build my career in regulatory affairs. Applying for my first job was pretty easy; I wanted to stay in the Boston area because of my family. I interviewed at three or four places, and the company just down the street from my home offered me the project manager position. It was a small company and I was employee number twelve or thirteen. I knew that working in a smaller company would allow me the opportunity to try a breadth of different things and I could interact with contract research organizations, our partners, as well as key opinion leaders. From there, I developed a network of people on the job and through consulting and professional associations. I subsequently found my next job through word of mouth, and the position after that I found when a headhunter contacted me. I found the job I have now through word of mouth. I didn’t deliberately network. I developed my network by collaborating and going to conferences and meetings. I haven’t restricted my networking to only regulatory affairs, as it helps to have a breadth of experience.

What advice would you give to someone interested in following a similar career path?

I would ask them to really see if they like doing this sort of work. It takes a certain skillset that includes the strategic aspect, scientific rationale, and confidence to make presentations both internally and externally and in key meetings that can make or break a product’s development. It’s also important to be able to lead a group of people from various specialties within the company and have good communication skills, both orally and in writing. Attention to detail is important as you’ll need to present a lot of information accurately and in an easy-to-convey manner. I believe I perform well in this job well because I know the details.

What would you have done differently in preparing for your career?

I can’t think of anything; I sort of let my career flow. Maybe others wouldn’t do this, but it’s worked for me. I never actively said that I want to be in a particular spot career-wise in five years. I don’t know if it would have made a difference to do so, but I have no regrets about where I am. I’ve never actively sought out a different job.

How much do you like what you do? Why? Is it what you imagined it would be? If not, how have you adapted?

I love what I do. Why? I can only do it in small companies, maybe 200–300 employees or less. I love it because I like to get into the details and the breadth and depth of knowing things about the pharmacology, chemistry, toxicology, and clinical aspects of a drug. I put my best foot forward in presenting data both internally and externally, from the early stages of drug development to getting it approved. I learn a lot and have challenges every week. It’s very dynamic, active, and intellectually stimulating and there will always be new challenges that I need to plan and prepare for.

How do you achieve career-life balance? Is this easy or hard to do? How many hours do you typically work per week?

This has changed over time. I had my son in graduate school and my daughter a few years after that. So, I have a husband and two kids. I think I’ve done a good job managing the balance. It used to be that both my husband and I would travel, so we had to check our calendars to make sure one of us would be in town for the kids. It was particularly brutal when I had to take very short trips to Europe and manage the travel and time changes. It was easier when the kids were younger and grew harder when my daughter hit her early teens, when she hated it even when I traveled to New Jersey for 1.5 days which I had to do often. It hasn’t been easy achieving balance, but I think I’ve done a good job. I would advise women to draw lines in the sand that they won’t cross. Try your best to be home for dinner. I think I always managed to do that when I was in town.

Having my son when I was in graduate school meant that I had to have a great deal of discipline and efficiency to get my work done. Other graduate students could start their day late and work late, but I had to be there from 8:30AM-5PM. You can’t care about what others think of the hours you keep. If your advisor or supervisor knows that progress is happening and you will get the job done, then it makes life easier. If you have to wait for your boss to leave work before you can leave, then life can be difficult. If something needs to be done, you need to focus and get it done. I was still social, but probably less so than others without kids.

How do you see your field changing in the next 5–10 years?

The field is changing and it will probably get harder before it gets easier. The FDA has been suffering from not having adequate staff. There’s a lot of incentive for senior FDA people to leave and do consulting work. There will soon be very young staff who may or may not have adequate mentoring and experience. There is very little that can substitute for experience. There is also a trend towards more regulation, which can mean longer timelines to approval for treatments. It’s challenging to overcome the perceptions that some people have about clinical trials and the regulations that might be put into place because of this.

Anything else you would like to share?

I have worked as a mentor with the Harvard Business Association for women in the biotech arena and get asked similar questions to the above. I struggle with this because I don’t know if I can give a clear career path for this field. If you ask five different people in regulatory affairs about their career path, you may get five different answers. I can only speak to my personal experience, and it might not be the same for others. The field is fun and challenging. Don’t worry too much about courses. Let life teach you.