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Rounit Raj

Founder, RegTale | Regulatory Affairs Trainee | CTD & Compliance | Documentation & Global Submissions

Moga

< 1 year of work experience

Regtale
Apr 20263 mosPresent

Punjab, India

Founded RegTale to bridge the critical gap between academic pharmaceutical theory and practical regulatory execution. Designed and developed a comprehensive digital simulation platform that replicates real-world eCTD, CTD, and ACTD dossier preparation and submission workflows. Key Focus Areas: • Hands-on Submission Simulator enabling interactive NDA/ANDA workflows with real-time validation. • Comprehensive Dossier Training modules covering CTD Modules 1-5. • Global Compliance hub aligning learning with US FDA, EMA, CDSCO, MHRA, TGA, and WHO guidelines. Actively collaborating with pharmacy institutions and industry mentors to empower the next generation of regulatory professionals with practical, industry-ready skills.
Jubilant Generics Limited
Jul 20251 moJul 2025

Greater Noida

• Gained exposure to pharmaceutical regulatory documentation • Learned basics of compliance processes and regulatory workflow • Assisted in document review and formatting • Developed understanding of regulatory requirements in the pharma industry

Education

ISF COLLEGE OF PHARMACY

Bachelor of Pharmacy - BPharm, Pharmacy

ISF COLLEGE OF PHARMACY

20224 yrs2026

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Headline

Founder, RegTale | Regulatory Affairs Trainee | CTD & Compliance | Documentation & Global Submissions

About

Pharmaceutical professional and Bachelor of Pharmacy graduate with a distinct focus on International Regulatory Affairs, CTD/eCTD dossier structures, and Drug Safety. Bridging the gap between traditional pharmacy education and digital compliance, I am the Founder of RegTale—a web-based eCTD workflow simulator designed to provide hands-on training in NDA/ANDA submission pipelines with real-time validation. Core Expertise & Focus Areas: Regulatory Affairs: Hands-on experience with CTD Modules 1-5, ACTD mapping, global regulatory guidelines (US FDA, EMA, CDSCO, MHRA, TGA, WHO), and electronic submission simulation workflows. Research & Communication: Proven capability in scientific literature evaluation and medical communication, recognized with a 2nd position in scientific poster presentations. Continuous Learning: Actively expanding expertise across comprehensive Pharmacovigilance (PV), Drug Safety protocols, and clinical research frameworks. Driven by a combination of pharmaceutical science and technical innovation, I am focused on scaling practical regulatory training solutions and exploring entry-level trajectories within Regulatory Affairs, Drug Safety, and Clinical Research. 📩 Open to high-impact opportunities, industry collaborations, and academic partnerships. Let's connect!

Location

Moga

Work experience

Founder & Chief Developer at Regtale, Apr 2026 - Present · 3 mos, Punjab, India, Founded RegTale to bridge the critical gap between academic pharmaceutical theory and practical regulatory execution. Designed and developed a comprehensive digital simulation platform that replicates real-world eCTD, CTD, and ACTD dossier preparation and submission workflows. Key Focus Areas: • Hands-on Submission Simulator enabling interactive NDA/ANDA workflows with real-time validation. • Comprehensive Dossier Training modules covering CTD Modules 1-5. • Global Compliance hub aligning learning with US FDA, EMA, CDSCO, MHRA, TGA, and WHO guidelines. Actively collaborating with pharmacy institutions and industry mentors to empower the next generation of regulatory professionals with practical, industry-ready skills.

Regulatory Affairs Trainee (Industrial Training) at Jubilant Generics Limited, Jul 2025 - Jul 2025 · 1 mo, Greater Noida, • Gained exposure to pharmaceutical regulatory documentation • Learned basics of compliance processes and regulatory workflow • Assisted in document review and formatting • Developed understanding of regulatory requirements in the pharma industry

Education

Bachelor of Pharmacy - BPharm, Pharmacy, ISF COLLEGE OF PHARMACY

Rounit Raj - Founder & Chief Developer in Moga | Tal