Bharat K.
Head Regulatory Affairs @INORX; Senior Regulatory & Clinical Strategy Consultant | Global Submissions | Biosimilars/Biologics/Peptides | Medical Devices | Regulatory Strategy Expert
- Role
- Head of Regulatory Affairs at Inorx
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Bharat K.
Clinical and CMC Regulatory professional experienced in EU, US and Domestic market Worked for Biosimilar, RDNA product, peptides product development.Vast experience in clincial research operations, project management, regulatory writing (Clinical study reports, IB, study protocol, module 2.4, module 2.5, module 2.6, Module module 2.7) and pharmacovigilance.Experience in EU MDR and US medical drug-device regulations. Human factor studies requirements for combination products. Notified body opinion for medical devices.
Experience
Head of Regulatory Affairs
Feb 2026 — Present · IN
Leading global regulatory strategy and scientific documentation for pharmaceutical, biologic, biosimilar, and medical device development programs. Responsible for building regulatory frameworks, supporting global submissions, and ensuring compliance with international regulatory requirements.Key responsibilities include:• Developing global regulatory strategies across US, EU, and India regulatory pathways• Leading preparation and review of IND, NDA, BLA, ANDA, and MAA regulatory submissions• Authoring and overseeing scientific and regulatory documentation including briefing books, clinical summaries, and regulatory responses• Supporting health authority interactions including US FDA, EMA, and CDSCO• Establishing regulatory processes, SOPs, and quality frameworks for CRO and product development programs• Providing strategic regulatory guidance across clinical development, CMC, and lifecycle management
Education
Savitribai Phule Pune University
Bachelor of Laws, Law
Savitribai Phule Pune University
Doctor of Philosophy, Pharmacology
Savitribai Phule Pune University
Master of Pharmacy, Pharmacology
Skills
- Regulatory Submissions
- Ich-Gcp
- Edc
- Ctms
- Lifesciences
- Validation
- Biochemistry
- Clinical Development
- Pharmaceutical Industry
- Fda
- CRO
- Medical Writing
- Clinical Monitoring
- Gcp
- Oncology
- Protocol
- Clinical Trials
- Pharmacovigilance
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