Vivek Chitale-Kamble

A Dynamic Senior Regulatory Affairs Project Leader with over 30 plus years of experience in regulatory affairs, Quality control and Quality Assurance, R&D, technical services in Active Pharmaceutical Ingredients (API) and Drug Products. Proven track record of preparing Drug Master Files and Drug Product submissions and registrations, while ensuring the compliance with global Heath Authorities. Successfully developed regulatory strategies leading to streamlined approvals.

With expertise in project management and technical assessments, poised to drive regulatory excellence and innovation in the industry, contributing significantly to organizational success.

Senior Regulatory Affairs Project Leader - Apotex Pharmachem Inc. - Brantford, ON, Canada

(2007-10)

• Prepare and review Drug Master Files (DMF/ CEP) and amendments for correctness and completeness and submit to the Health Authorities worldwide
• Review and provide the CMC information for NDA / ANDA / ANDs / MA applications
• Prepare and submit electronic submissions (e-CTD-Docubridge & NeeS) to the Health Authorities
• Initiate the projects and keep the project status / tracking system current (PLCM)
• Review, prepare and submit the deficiency responses to the Health Authorities worldwide
• Provide regulatory impact assessment for change controls, deviations etc.
• Assessment of regulatory filing classification for post approval changes
• Liaison with global affiliated sites for various projects
• Provide project related technical inputs to the associates
• Develop regulatory strategies for submissions

General Manager- Regulatory Affairs - USV Limited - Mumbai, India

(2005-11 - 2006-06)

Dy. General Manager- Regulatory Affairs - Unichem Laboratories Limited - Mumbai, India

(1999-08 - 2005-10)

Senior Manager- Technical Services & Regulatory Affairs - IPCA Laboratories Limited, International Division - Mumbai, India

(1996-10 - 1999-08)

Manager- Drug Regulatory Affairs - Ranbaxy Laboratories Limited - New Delhi, India

(1994-01 - 1996-10)

QA & Analytical Development Executive - Kopran Limited - Mumbai, India

(1992-01 - 1994-01)

Senior QA & QC officer - Cophar Laboratories Limited - Mumbai, India

(1989-11 - 1992-01)

Doctor of Philosophy - Analytical Chemistry - University of Mumbai (Bombay)