Mitul Tilala, a Regulatory Affairs professional from the pharmaceutical and biotechnology sectors, talks about his journey and transition.
Q: Can you share your experience transitioning from working in generic pharmaceuticals to branded pharmaceuticals?
Mitul Tilala: Absolutely. Transitioning from generic pharmaceuticals to branded pharmaceuticals was a significant yet rewarding shift in my career.
Q: What motivated you to make this transition?
Mitul Tilala: I was motivated by a desire to broaden my skill set and gain exposure to different facets of the pharmaceutical industry. While I had valuable experience in generic pharmaceuticals, I saw an opportunity to tackle new challenges and expand my expertise in regulatory affairs by moving into the branded pharmaceutical sector.
Q: What were some of the key differences you encountered between working in generic versus branded pharmaceuticals?
Mitul Tilala: One of the main differences was the level of complexity and specialization in branded pharmaceuticals. Branded products often involve more intricate formulations, novel drug delivery systems, and unique regulatory pathways compared to generics. Additionally, there is a greater emphasis on innovation, market exclusivity, and strategic planning in the branded pharmaceutical sector.
Q: How did you adapt to the transition and navigate the learning curve?
Mitul Tilala: Adapting to the transition required a proactive approach to learning and a willingness to embrace new challenges. I familiarized myself with the specific regulatory requirements, product portfolios, and strategic priorities of the branded pharmaceutical company. I sought mentorship from experienced colleagues and engaged in continuous professional development to enhance my knowledge and skills.
Q: Can you share a specific example of how your experience in generics prepared you for your role in branded pharmaceuticals?
Mitul Tilala: My experience in generics provided a solid foundation in regulatory affairs, project management, and compliance standards, which proved invaluable in branded pharmaceuticals. For instance, my expertise in post-approval submissions and managing regulatory compliance issues in generics laid the groundwork for handling similar challenges in branded pharmaceuticals, albeit with greater complexity and strategic considerations.
Q: What advice would you offer to others considering a similar transition in their careers?
Mitul Tilala: Approach the transition with an open mind, a willingness to learn, and a proactive attitude. Take advantage of professional development opportunities, seek mentorship from experienced colleagues, and leverage your existing skills to add value in your new role. Embrace the learning curve as a growth opportunity and continuously strive to expand your knowledge and capabilities in the dynamic pharmaceutical industry.
About Mitul Tilala:
Mitul Tilala is a seasoned Regulatory Affairs professional with over 12 years of experience in the pharmaceutical and biotechnology sectors. Currently, he serves as a Regulatory Affairs Manager at Eikon Therapeutics, where he develops and executes comprehensive CMC strategies and collaborates with cross-functional teams to ensure compliance with regulatory requirements.
Mitul has a rich professional background, having held key positions at Genpact LLC, Alvogen Inc., Heritage Pharma Labs Inc., and Pharbest Pharmaceuticals, Inc. His extensive experience includes preparing and submitting NDAs, ANDAs, IMPDs, and CTAs, managing global submissions, and ensuring regulatory compliance across various product life cycles. He has demonstrated expertise in project management, post-approval activities, and vendor relations, and has received multiple accolades, including a Star Silver award from Organon for outstanding performance.
Mitul holds an MBA in International Business from Goldey-Beacom College and an MS in Pharmacy Administration from Long Island University. His educational background also includes a BS in Pharmacy from Rajiv Gandhi University of Health Sciences. Throughout his career, Mitul has been committed to continuous learning and professional development, which has equipped him with a diverse skill set and the ability to navigate the complexities of both generic and branded pharmaceutical sectors.
In addition to his professional accomplishments, Mitul has contributed to academic research and teaching, having served as a Graduate Teaching Assistant and Research Assistant at Long Island University. He is skilled in a wide range of computer applications and systems, including Microsoft Office Suite, Docubridge, Medxview, and Veevavault RSDM.
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