Harish Chander
Senior Manager Regulatory Affairs, Mankind Pharma Ltd | Ex: CDSCO, Fresenius Kabi, Medicom Healthcare, JSS Medical Research
- Role
- Senior Manager Regulatory Affairs at MANKIND PHARMA LTD
- Location
- North Delhi, DL, IN
- LinkedIn followers
- 500 followers
About Harish Chander
Having more than 13 years of experience, thorough knowledge and skills regarding Registration of Drugs,Medical Devices, Diagnostics & Cosmetics in India, Clinical trials, BA/BE studies and Pharmacovigilance. Well versed with Drugs & Cosmetics Act 1940 and Rules 1945, New Drugs and Clinical Trial Rules 2019, Medical Device Rules 2017, Cosmetics Rules 2020 & ICH/GCP guidelines.
Experience
Senior Manager Regulatory Affairs
Jan 2026 — Present · Delhi, IN
Responsible for registration of drugs, medical devices & cosmetics in IndiaSubmission of Import and Registration application, New Drug application, Subsequent New Drug application (Pharmaceutical) and Import license application ( Medical device) via SUGAM portal/ NSWS portal to the CDSCO Provide Regulatory Strategy to CFT for timely launch of the Drug and Medical Device in IndiaReview and submission of dossier for marketing Authorization, registration and clinical trial of drugs and medical devices with CDSCO officeCoordination and participation in the Subject Expert Committee meetings (SEC) Responsible for the testing of new drugs at IPC Ghaziabad, NIB, CDTL, CDL and other testing laboratoriesExecute strategies for timely regulatory approvalsSubmission of drug dossier to the Saudi Arabia FDAManaging Pharmacovigilance related documents submission to the Regulatory Authorities
Education
Govt Boys Sr Sec School Shakti Nagar No 1 Delhi
12, Science
2001 — 2005
Department of Pharmaceutical Sciences Bhimtal Campus Nainital
Master of Pharmacy, Pharmacy
2010 — 2012
Skills
- Regulatory Affairs
- C
- Pharmacology
- Pharmacovigilance
- Clinical Trials
- Ich-Gcp
- Regulatory Submissions
- Gcp
- CRO
- Clinical Data Management
- Clinical Monitoring
- Clinical Research
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