Dr. Ashitha Joseph on Building a Career Beyond Pharm D: From India to Northeastern University, Boston
In the ever-evolving world of pharmaceuticals, career paths are often defined by resilience, adaptability and a drive for excellence. Dr. Ashitha Joseph embodies all three. A Pharm D graduate (Batch of 2022) from KLE College of Pharmacy, Belagavi, Karnataka; currently pursuing her MSc in Regulatory Affairs at Northeastern University, Boston who carved her niche in R&D Quality and Compliance, she has worked with prominent global companies, including Moderna, where she progressed from a summer intern to an essential co-op position. Her journey reflects not only professional advancement but also determination and clarity in a field where many recent graduates feel uncertain about their direction.
In this interview with Dr. Rametrika Saha of MedBound Times, Dr. Ashitha Joseph shares her inspiring career journey, the lessons learned along the way and her advice for aspiring healthcare professionals looking to navigate the pharma industry with confidence.
Can you introduce yourself to our readers?
Dr. Ashitha Joseph: I’m Ashitha Joseph, originally from India where I completed my Pharm D. Right now, I’m based in Boston pursuing my Master’s in Regulatory Affairs at Northeastern University. Over the past few years, I’ve had the chance to work in medical affairs, clinical research and most recently in quality compliance during my co-op at Moderna. What excites me most about this field is the balance between science and regulation, and how both come together to make sure patients get safe and effective treatments.
Was there a “defining moment” when you realized regulatory science was your calling?
Dr. Ashitha Joseph: Yes, there definitely was a defining moment for me. During my time as a Medical Advisor in the cardio-diabetic space at Aprica Healthcare pvt.Ltd, I worked closely with physicians and the marketing team to provide scientific input on cardio-diabetic drugs like dapagliflozin and vildagliptin, as well as on a OTC Continuous glucose monitoring device. Since these therapies were relatively new at the time in Indian Market, a big part of my role involved reviewing clinical data, answering safety and efficacy questions, and making sure the information we shared was accurate and responsible. With dapagliflozin especially, I followed its expanding approvals closely—including its 2021 indication for chronic kidney disease and, later, its 2023 approval for all patients with heart failure.
That’s when I found myself digging deeper into the approval pathways and regulatory requirements behind these products. It struck me that while I was contributing to patient safety on the communication and clinical side, there was a whole other dimension, ensuring these drugs and devices could even reach patients in the first place through rigorous regulatory review, quality systems, and compliance.
That realization was my turning point. I thought, if I’ve experienced one end of patient safety, why not explore the other- the regulatory and quality side that underpins the entire process? That curiosity became my motivation to pursue regulatory science, and it’s what continues to inspire me today.
Could you walk us through your journey from being a Pharm.D graduate in India to pursuing an MS in Regulatory Affairs at Northeastern University?
Dr. Ashitha Joseph: I pursued my Pharm.D at KLE College of Pharmacy, Belagavi, Karnataka, one of the most renowned institutions in India offering the Pharm.D degree. Those six years (2016–2022) gave me a strong academic foundation, but also shaped my ambition and drive. I was fortunate to learn under inspiring professors and to be part of a university environment that encouraged both skill-building and personal development. Along the way, I was honored with the Tata Trust Scholarship, recognized as the Meritorious Girl Student, and awarded the title of Best Outgoing Student of my batch.
During my Pharm.D, I actively sought out opportunities beyond the classroom. I completed internships in quality assurance and clinical research, presented at conferences, and even won a national-level oral presentation competition. These experiences deepened my interest in the broader impact pharmacists can have, not just at the bedside, but in shaping drug development and regulatory pathways.
Of course, the journey as an international student brought new challenges. Like many of my classmates, I faced the uncertainty of finding a co-op. What kept me motivated was trusting my foundation from Pharm.D and leaning on the transferable skills I had built, critical thinking, communication, and a patient-centric mindset.
At Northeastern, pursuing an MS in Regulatory Affairs under the College of Professional Studies has been a transformative step. I was grateful to receive the CPS Dean’s List Scholarship, and the program’s focus on experiential learning has allowed me to intern and collaborate on projects with companies, gaining real-world exposure. Looking back, the transition from a Pharm.D in India to Regulatory Affairs in Boston feels like a natural progression, each step has built on the last, driven by the same ambition I carried from my early student days.
What are the challenges you have faced after moving from KLE to Northeastern University?
Dr. Ashitha Joseph: One of the biggest challenges I faced moving from KLE to Northeastern was the shift in environment and expectations. At KLE, I had a strong support system with professors who guided me closely, and the academic structure felt familiar and comfortable. Coming to the U.S. as an international student was very different, suddenly I had to adapt to a new education system, cultural differences, and even things like communicating more openly in class discussions.
The co-op search was another challenge. It was very different from what I was used to in India, you need to actively network, tailor your applications, and stay consistent. It took time to understand how to navigate that process, but it also made me more resourceful and proactive.
On a personal level, balancing coursework with part-time oncampus jobs, managing time effectively, and adjusting to life in Boston, especially with homesickness, were real challenges. But over time, these experiences made me more adaptable and taught me the importance of building a strong support system with peers and mentors.
You worked with Moderna, that's truly commendable. How did the experience of a summer internship lead to an extended six-month co-op in R&D Quality & Compliance?
Dr. Ashitha Joseph: That was actually an interesting turn of events. My original application was for a two-month summer internship, but during the interview I communicated my flexibility to start earlier and my eagerness to learn for a longer period. The team appreciated that, and what began as a summer role was extended into a full six-month co-op in R&D Quality & Compliance at Moderna.
During my time there, I worked on a variety of projects, supporting FDA and global health authority inspections, managing audit and CAPA records in Veeva Vault, preparing compliance reports and even building dashboards to track key quality metrics. I also had the chance to support vendor audits and collaborate with different functional teams, which gave me a broader view of how quality systems tie into R&D activities.
The experience gave me not just technical skills, but also exposure to how a large biotech operates in real time, balancing innovation with compliance. Looking back, I think that willingness to be flexible and open at the start really set the stage for an experience that shaped my career direction.
Do you think AI and digital tools (like Veeva Vault) will change the way compliance and documentation are managed?
Dr. Ashitha Joseph: Yes, I do think AI and digital tools are transforming how compliance and documentation are managed. Platforms like Veeva Vault, MasterControl, and LabWare LIMS have already made a big difference by streamlining document control, audit trails, and quality workflows, reducing manual errors and saving time.
On the AI side, the FDA’s January 2025 draft guidance on the use of Artificial Intelligence to support regulatory decision-making is a major milestone. It shows that regulators are not only open to AI but are beginning to set expectations around credibility, transparency, and risk management when these tools are used in drug development and review.
For students and young professionals, this means having at least a basic understanding of AI and digital systems is no longer optional. Building these skills, and showing them on your résumé, can really help you stand out in interviews. Employers are looking for candidates who can bridge traditional regulatory knowledge with digital fluency, so reflecting these competencies can make a strong impression.
What is the most misunderstood aspect of regulatory affairs that you wish more people knew?
Dr. Ashitha Joseph: I think the most misunderstood part of regulatory affairs is that people assume it’s just paperwork or form-filling and approvals. In reality, it’s much more hands-on and strategic. For example, when a new drug or device is being developed, the regulatory team is often the one guiding whether it needs a full clinical trial, what data regulators will expect, or how the label should be worded so doctors and patients can actually use it safely.
It’s not about “slowing things down” with rules, it’s about finding the safest, most efficient path forward. I like to think of it as being the navigator of the journey: the scientists and clinicians are driving the car, but regulatory affairs is the GPS that makes sure they don’t take a wrong turn and can actually reach the destination- the patients.
That’s why I wish more people saw regulatory affairs as a partner in innovation, not just paperwork. Because without that guidance, even the best therapy might never reach the patients who need it.
What do you see as the biggest differences between the regulatory landscapes in India vs. the U.S.?
Dr. Ashitha Joseph: When I compare the regulatory landscapes of India and the U.S., what strikes me first is the difference in maturity and global alignment. In the U.S., the FDA follows highly structured frameworks like 21 CFR Parts 11, 210, 211 for GMP and data integrity, and ICH guidelines are deeply embedded into regulatory decision-making. In India, the CDSCO has been strengthening its processes, but the degree of harmonization with ICH standards is still evolving.
Another big difference is in clinical trial oversight. In the U.S., processes like IND applications and ClinicalTrials.gov registration are mandatory and very transparent. In India, clinical trial regulations were significantly updated after the 2013–2014 amendments, introducing stricter ethics committee roles, SAE reporting timelines, and compensation rules. These reforms made the environment more robust but still different in terms of consistency and enforcement compared to the FDA system.
There’s also a contrast in post-marketing surveillance. The FDA has a well-established system like FAERS (FDA Adverse Event Reporting System), while India’s PvPI (Pharmacovigilance Programme of India) is expanding but still building capacity in terms of reporting culture and infrastructure.
Finally, the use of digital systems and transparency stands out. Tools like eCTD submissions, electronic portals, and inspection databases are standard in the U.S., while in India, digital adoption is growing but still catching up.
Both regulators aim for patient safety, but the U.S. system is more standardized and globally harmonized, while India is in a phase of modernization with some flexibility but also variability.
Balancing life abroad, studies and high-stakes work isn’t easy — how do you keep yourself motivated?
Dr. Ashitha Joseph: I stay motivated by keeping in touch with a few close friends and seniors from my Pharm.D days, they’ve been a constant source of encouragement. My professors from KLE also continue to support me and appreciate my work, which means a lot. I make it a point to reward myself once in a while by shopping, traveling, or exploring new places. And of course, having good friends and mentors here keeps me grounded and motivated through the challenges.
Do you think India is moving towards global regulatory alignment (like with FDA/EMA), and what steps are still needed?
Dr. Ashitha Joseph: Yes, India is making steady progress toward global regulatory alignment, which is key to its role as a major pharmaceutical hub. A landmark step was the Indian Pharmacopoeia Commission (IPC) joining the Pharmacopoeial Discussion Group (PDG) in October 2023, after completing a one-year pilot program. This made India a standards maker alongside the U.S., EU, and Japan, strengthening trust in Indian drug quality. On the ICH front, the Central Drugs Standard Control Organisation (CDSCO) is currently an observer of the International Council for Harmonisation (ICH). Alongside these milestones, India has reformed its domestic framework through the 2019 New Drugs and Clinical Trials Rules, the 2023 Schedule M revision aligning GMPs closer to FDA/EMA levels, and the adoption of reliance pathways to speed approvals for drugs already cleared in stringent markets.
Still, more work is needed for full alignment. India must strengthen inspection and enforcement, since quality lapses continue to raise global concerns. It also needs to expand post-market surveillance and pharmacovigilance to ensure long-term patient safety. The medical device regulatory framework requires more clarity and infrastructure to match global systems like FDA’s CDRH or EU MDR. Finally, greater digitization and in-house scientific capacity within CDSCO will be crucial to build transparency, consistency, and international confidence in India’s regulatory system.
Many Pharm.D graduates are curious about career paths beyond clinical practice. What advice would you give them about exploring regulatory affairs?
Dr. Ashitha Joseph: I’d say the biggest thing is to keep an open mind. As Pharm.D graduates, we’re trained to think in a patient-centric way, and that perspective is just as valuable outside clinical practice. Regulatory affairs may not be the first path that comes to mind, but it’s all about ensuring safe, effective, high-quality medicines reach patients , which aligns with our training.
From my own experience, internships were game-changers. Working in clinical research, medical affairs, and later regulatory/quality gave me practical insight and helped me discover what resonated with me. Adding certifications like ICH-GCP, GMP, or pharmacovigilance courses also built credibility and gave me confidence stepping into new roles. My advice is to use your student years to explore, through internships, short projects, networking through LinkedIn, and certifications, because those experiences not only sharpen your skills but also open doors to careers beyond the traditional Pharm D path.
If you had to sum up your career journey so far in one word or phrase, what would it be?
Dr. Ashitha Joseph: I’d choose Steve Jobs' words: ‘Stay hungry, stay foolish.’
I’m still paving my path, there are challenges, but I remain ambitious, eager to learn and open to new opportunities.
MedBound Times extends a heartfelt gratitude to Dr. Ashitha Joseph for sharing her valuable insights on our platform.
