Gayathri Manoj

Master of Science in Regulatory Affairs

April 2026 Graduate


Where are you from, or where do you consider home?

I’m from India, but home has never been just one place for me. I grew up in Muscat, Oman, found my passion back in India, and Boston has become my first home in the U.S. Each place has shaped a part of who I am, and together they remind me that home is wherever you choose to grow.

Three words to describe your experience at Northeastern:

Resilience. Purpose. Perseverance.

What motivated you to continue through challenging times in pursuit of your degree?

Passion carried me through. Even on the days when showing up felt difficult, my commitment to this field kept pushing me forward.

Regulatory affairs was never a career I envisioned. It found me in a way I never imagined. As a biotechnology graduate, I had no formal grounding in regulation. Unlike pharmacy programs, it was not part of our curriculum. Yet after nearly two years building vaccine dossiers at Bharat Biotech, I knew with certainty that this was where I belonged.

I was always drawn to the intersection of technology and healthcare, and that pull led me to pivot from pharmaceuticals to medical devices. The transition was demanding. Every class and assignment introduced regulations I had never worked with before. The toughest challenge was the co-op search, with its long stretch of applications, rejections, and quiet moments of doubt.

When I joined Aztech Regulatory & Quality, the efforts began to compound. I led two FDA 510(k) submissions for sleep apnea devices, prepared a Health Canada Class III application for a dental implant, and mapped regulatory pathways for a wide range of devices. Passion for what you do can carry you miles. It carried me across continents, and it’s still carrying me forward today.

What has your journey revealed to you about yourself?

Northeastern made me realize the potential within me that I had never truly tapped into and taught me that nothing meaningful unfolds until you’re willing to work for it.

I learned early that opportunities rarely arrive on their own. My on-campus job came from a referral I almost hesitated to ask for. My co-op came through paths most students wouldn’t think to explore. I began networking in my very first quarter and applied for co-ops before I was even eligible, not because I was certain of the outcome, but because I understood that every door I knocked on increased the odds that one would open.

What held me back was never a lack of opportunity. It was fear. Northeastern taught me to move through that fear rather than around it. In doing so, I discovered that I am someone who creates her own opportunities.

Experiential learning is a core component of a Northeastern education. Describe some of the highlights for you.

What sets Northeastern apart is that experiential learning isn’t a single milestone. It is woven through the entire degree. Students engage with employers through course-based projects, co-op, and capstone, each offering a different lens.

My first experiential learning began before I was even eligible for co-op. Through an Experiential Network course, I joined a team partnering with Sen-Jam Pharmaceutical to explore how cryptocurrency and blockchain could help fund early-stage drug development. It was a subject I knew nothing about, which is exactly why I chose it. Over several weeks, we worked closely with the company, defined our scope, and presented our findings in a session with C-suite leaders. The experience taught me that stepping into unfamiliar territory is often where the most meaningful learning happens.

My co-op at Aztech Regulatory & Quality and my capstone project at Statera Regulatory Consulting laid the foundation for my journey ahead. Each experience led to the next opportunity and gave me the confidence to keep going.

Where do you imagine yourself five years from now?

In five years, I see myself leading a digital health venture of my own, one built with regulatory thinking at its core rather than treated as an afterthought.

Over the past four years, I have witnessed almost every point in a product’s journey. I built vaccine dossiers for global markets, managed clinical trial studies across three countries, and guided medical devices through FDA and Health Canada MDR frameworks. Along the way, I noticed a recurring pattern. Brilliant innovations rarely fail because the science is weak. They fail because the path to patients is misunderstood, underestimated, or discovered too late.

That realization grew sharper as I mentored founders through the MeHI Digital Health Sandbox program and served as a judge for Harvard Medical School’s MEDscience TECH program.

The company I envision will sit at that intersection, pairing technology that solves real clinical problems with the regulatory discipline to bring it to patients safely and quickly. Regulatory affairs taught me how healthcare innovation reaches the world. Entrepreneurship is how I intend to shape what reaches it next.

Knock on the doors that intimidate you, ask for the help you hesitate to request, and trust that every effort of yours will compound over time.

Gayathri Manoj
What advice would you give to current and future Huskies?

Knock on the doors that intimidate you, ask for the help you hesitate to request, and trust that every effort of yours will compound over time. The path rarely looks clear from the beginning, but it reveals itself to those willing to take the first step. Always believe that your journey may surprise you in ways you never imagined.

Is there anything else you wanted to say that we didn’t cover?

Beyond my work, giving back has become one of the most meaningful and cherished parts of my journey. So many people opened doors for me, and I want to do the same for others. Today, I chair the Patient Engagement group for TOPRA, serve as a Review Panel member at CISCRP, and mentor young innovators through BioBuilder and founders through the MeHI Digital Health Sandbox program. I’m genuinely eager and excited to help fellow Huskies in any way I can.

Connect with Gayathri on LinkedIn.