1. Gunjan Bhavik Joshi
E mail ID : gunjanjani@yahoo.co.in
Mobile :+91-9535366021
Bangalore
SUMMARY
Quality experience of over 12 years in working in Regulatory Affairs division for generic and innovator
Pharmaceutical companies. Expertise in working on regulatory requirements of wide range of markets,
coordinated with Internal and external customers/stakeholders, worked on different systems and
processes as per Global standards.
EDUCATION
• B. Pharm from Gujarat University
• Registered Patent Agent of Government of India. Registration No. IN / PA – 1019
• General course on Intellectual Property (Distance Learning) from WIPO Worldwide Academy.
EXPERIENCE
Organization : AstraZeneca India Pvt Ltd
Duration : August 2010-January 2015 (4.5 years)
Designation : Assistant Manager – Regulatory Affairs
Branded Generics
• Responsible for Preparing, Project Manage and execute regulatory plans for Branded Generic
products to achieve and maintain successful regulatory approvals according to agreed strategy
and business priorities.
• Contributed to the Identification and Implementation of solution to regulatory issues alongside
external partners/vendor companies and AZ Marketing Companies.
• Worked Collaboratively with AZ Marketing Companies and External Regulatory Partner/ vendor
companies to achieve and maintain successful regulatory approvals, optimum market access,
and Regulatory compliance ; in line with Global AZ standards and processes.
• Interfaced with external partners/vendor companies and AZ Marketing Companies for Regulatory
submission content & format, Use of common systems & processes, assisting communication
and development of processes, replying HA questions, Obtaining PI update information for
regulatory submission and to establish and maintain honest and trusting relationship.
• Responsible for guiding and managing team members for dossier compilation, review and
submission, handling different queries and requests, communication across various AZ Marketing
companies.
• Have worked on various OPIs, SOPs, workflows and processess.

2. Gunjan Bhavik Joshi
E mail ID : gunjanjani@yahoo.co.in
Mobile :+91-9535366021
Bangalore
Key Achievements :
• With my continuous efforts ; persuaded marketing companies to have confidence on generic
product registration.
• Bridged the gap between Indian generic vendors & Global customers (AZ MC’s)
CMCRC (Chemistry, Manufacturing and Control Regulatory Compliance)
Worked on Chemistry, Manufacturing and Control (CMC) documentation for designated commercial
products; post approval, in line with Global AZ Standards and Processes.
• Timely submission of Post Approval CMC documentation for various licence renewals, MAAs,
Variations, Query Response, Annual reports accros the globe.
• Update all relevant electronic records & systems to be consistent with regulatory submissions and
commitments.
• Notify Manufacturing sites of Health Authority approval/ withdrawal.
• Demonstrate compliance with departmental and company standard operational procedures &
processes.
Key Achievement:
• Designed and Facilitated Learning and sharing sessions for India Team; which was well received
by Team and made differences with future deliverables.
Organization : Strides Arcolab
Duration : February 2010 - July 2010
Designation : Senior Executive – Regulatory Affairs
• Worked with External customer for Registration in Emerging markets.
• Coordination and communication between External customer and Quality control, PD &
Manufacturing site to provide required documents , samples & standards.
• Worked with Marketing department to plan & project manage dossier preparation, submission &
approval.
Organization: Lupin Limited, Mumbai
Duration: April 2005 – August 2009

3. Gunjan Bhavik Joshi
E mail ID : gunjanjani@yahoo.co.in
Mobile :+91-9535366021
Bangalore
Designation: Senior Executive – Regulatory Affairs
• Registration of Anti Tubercular Products, Cephalosporin Antibiotics, Herbal Formulations in CIS
Region.
• Responsible for addressing Queries & Additional documents required as a part of Product
Registration & Finalization of NTD in co ordination with Respective offices and plant.
• Have worked on Anti Tubercular Products for WHO Prequalification Programme (A United
Nations Programme managed by WHO)
April 2003-April 2005
• During this period I worked for companies like Glenmark Pharmaceutical Limited, Famy Care
Limited, Ajanta Pharma Limited and Claris Life science Limited.
• Major experience was working for Emerging markets of MEA, APAC & LATAM Region on
Antibacterial, Oral Contraceptive & Herbal Formulations.
PERSONAL DETAILS
DOB : 24th
June 1981
Marital Status: Married
Language Known: English, Gujarati, Hindi, Marathi & Kanadda.
Interest & Hobbies : Singing & listening Music , Reading