Dhiraj Lanjewar
Regulatory Affairs - EU, USFDA, CDSCO | EU MDR 2017/745, 510k, MDR 2017 Compliance | Clinical Investigation of MD | Materiovigilance | M.Pharm (Regulatory Affairs) | B.Pharm | D.Pharm
- Role
- Regulatory Affairs Executive at Bioexcel
- Location
- Nagpur, MH, IN
- LinkedIn followers
- 500 followers
About Dhiraj Lanjewar
I am a dedicated Regulatory Affairs professional with an M.Pharm in Pharmaceutical Regulatory Affairs and B.Pharm, D.Pharm qualifications. I began my career as an RA intern in medical devices and gained experience in preparing Clinical Evaluation Reports (CERs), Clinical Investigation Protocols (CIP), as per EU MDR 2017/745, ISO 14155, ISO 14971, and MEDDEV guidelines and also assisted in preparing CRFs and data sheets. I have learned about the materiovigilance process, skilled in gap assessment/ non-conformities, and handling MD-15 applications and import licenses per CDSCO requirements. Proficient in regulatory documentation, literature analysis, and compliance verification across EU, USA, and India. Passionate about applying regulatory expertise to strengthen compliance systems, enhance submission quality, and promote the development of safe and effective medical products.Iām looking for opportunities where I can apply my regulatory knowledge, documentation expertise, and vigilance experience to support compliance, safety, and innovation in the healthcare sector. Open to work in Drug Section also.š¤ Open to full-time roles or Apprenticeship or internships in Regulatory Affairs, Quality Assurance, and Medical Device/Pharmaceutical Regulatory Documentation.
Experience
Regulatory Affairs Executive
Sep 2025 ā Present Ā· Nagpur, IN
Education
Anurag College of Pharmacy, Warthi, Bhandara
Bachelor's of Pharmacy, Pharmaceutical Sciences
2020 ā 2023
Sree Narayana Vidhyaalaya English Medium High School & Jr. College, kanhan
High School & Jr. College, Physical Sciences
2016 ā 2018
Rashtrasant Tukadoji Maharaj Nagpur University (RTMNU)
Smt. Kishoritai Bhoyar College of Pharmacy, kamptee, Nagpur Master's degree, Regulatory Affairs
Smt. Shantabai Patil Institute of Diploma in Pharmacy, Kamptee, Nagpur
Diploma in pharmacy, Pharmacy, Pharmaceutical Sciences, and Administration
2018 ā 2020
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