Anshuman Shettigar
Regulatory Affairs Intern at Medicinal Genomics | Graduate Student in MS Regulatory Affairs at Northeastern University | Bachelor of Pharmacy
- Role
- Regulatory Affairs Intern at Medicinal Genomics
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Anshuman Shettigar
Aspiring regulatory affairs professional with a strong foundation in pharmaceuticals and medical devices, currently pursuing an MS in Regulatory Affairs at Northeastern University. My academic journey, coupled with hands-on experience, has equipped me with a comprehensive understanding of regulatory strategies, compliance practices, and product development processes. Key experiences include- Spearheading the \"Toxic Cocktail Campaign\" at The J Healthcare Initiative, addressing the opioid crisis and enhancing community safety- Contributing to ANDA submissions and improving compliance processes during my internship at Glenmark Pharmaceutical- Conducting in-depth research on regulatory strategies for both pharmaceutical products (CardioNitra) and medical devices (Abiomed Impella Left-Sided Blood Pumps). I possess a robust skill set encompassing FDA guidelines, ICH standards, and ISO norms (13485, 14971). My expertise extends to various regulatory submissions (IND, NDA, BLA, 510(k), PMA), quality management systems, and risk analysis techniques like FMEA. Committed to advancing patient safety and product efficacy, I am eager to leverage my multifaceted background in pharmaceuticals and medical devices to contribute to innovative regulatory solutions. My goal is to navigate complex regulatory landscapes, ensuring compliance while facilitating the development and market access of life-changing healthcare products.
Experience
Regulatory Affairs Intern
Apr 2025 — Present · US
Education
Northeastern University
Master of Science - MS
2023 — 2025
Hiranandani Foundation School
ISC
2018 — 2019
Manipal Academy of Higher Education
Bachelor of Pharmacy - BPharm
2019 — 2023
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