CURRICULUM VITAE

Shailesh Mohan Ailwar

C***, Sapphire Block, Devi Homes,

Bachupally, Hyderabad-500090

Mobile : +91-982*******

adofva@r.postjobfree.com

Application for: Regulatory Affairs- CMC (Biosimilars/Biologics)

PROFILE

Having 8 years of rich experience in managing and executing regulatory affairs operations for Registration, Post-Approval variations, Renewal of Biological/Biosimilar and Pharmaceutical products around the globe including US, EU, APAC, CIS, FWA & other ROW markets.

EDUCATIONAL QUALIFICATION

Education

Board / university

Year of Passing

Class/Percentage

Master of Pharmacy

(Pharmaceutics)

R.T.M.N.U Nagpur

2013

71.66 %

Bachelor of Pharmacy

R.T.M.N.U Nagpur

2011

64.68 %

Qualified GPAT/GATE Exam in 2011

WORK EXPERIANCE

Organization

Designation

Year of Exp.

Sanofi Healthcare India Private Limited

Deputy Manager

May-2021-till Now

Biocon Biologics India Limited, Bangalore

Assistant Manager

Oct 2019–May 2021

Indegene Pvt. Ltd, Bangalore

Sr. Associate

Jun 2019- Sept 2019

Genpact India Private Limited, Mumbai

Lead Associate

Jun 2016- Jun 2019

Ajanta Pharma Limited, Mumbai

Senior Office

Nov 2015 - May 2016

Indoco Remedies Limited, Mumbai

Junior Officer

May 2013 - Nov 2015

Experience/ Responsibility:

Sanofi Healthcare India Private Limited:

LCM for Vaccines and Insulin product (Dossier Preparation, Variations, Query response) for ROW (Thailand, Indonesia, Uganda, and WHO).

Biocon Biologics India Limited:

Dossier Preparation CTD/ACTD/Country Specific for international market and domestic market for Biological Products.

Variation filling (Major and Minor)

To evaluate & respond to any regulatory query from health authority

To review technical documents for dossier compilation/authoring

To maintain & Update all documentation & dossier record.

Indegene Pvt. Ltd: (AstraZeneca Client)

Initiating, planning, and executing preparation of New submission/renewal packages for ROW market for pharmaceutical product/Biosimilar

Performing Post approval CMC activity (Renewal and Variations)

Roles in Genpact India Private Limited – (Pfizer Client)

Initiating, planning, and executing preparation of re-registration/renewal packages for ROW market for Biological Product and pharmaceutical products.

Performing Post approval CMC activity of Biological product and pharmaceutical products for US Market, renewal, and variation for ROW market

Monitoring of team projects, providing team training and on boarding of new team members

Provide regulatory support and inputs for finalization of strategy for renewals and variation submission in Global markets

Maintain regulatory work processes and tracking tools that improve performance levels and transparency

Execution and submission of the assigned projects well within the prescribed timelines

Ensuring maintenance of product and license information in the tracking database

Regular teleconferencing with cross functional departments, stakeholders and regional regulatory colleagues for finalizing strategies, change controls and timely delivery of renewal, variation packages

Performing Gap Analysis to perform the change control for the registered products

Experienced in handling and managing renewal projects using various software including Document management system (Veeva, GDMS, ARS, GCMC, PDM, SPA tracker) and other analytical or business tools

Roles in Ajanta Pharma Limited

Preparation of Registration dossier (CTD and Country Specific Formats) for various countries worldwide

CIS – Kazakhstan, Kyrgyzstan, Ukraine and Uzbekistan

AFRICA- Kenya, Ethiopia, Uganda and Tanzania

Evaluation and submission of the deficiency’s responses received from respective health ministry

Preparation and Review of Renewal for the products as per country requirement

Change controlled Management

Co-ordination with Various departments R&D, International business development team, QA, QC and Plant for timely submission of Registration, Re-Registration Dossiers, variation to Respective MoH

Roles in Indoco Remedies ltd (R&D)

Preparation of Registration and Re-Registration Dossiers (CTD, ACTD and Country Specific Formats) for various countries worldwide

ASEAN - Malaysia, Philippines, Myanmar, and Vietnam

AFRICAN- FWA, Tanzania, Kenya, Nigeria, Mozambique

LATIN American - Colombia, Bolivia, Chile and Peru

CIS – Kazakhstan, Kyrgyzstan, Ukraine and Uzbekistan

Evaluation and submission of the deficiency’s responses received from respective health ministry

Preparation of Monthly Plan of Dossier Submission and data base management

Good coordination with global stake holder for smooth and timely completion for the regulatory submissions

Drug product life cycle management for Registration Dossiers

Co-ordination with Various departments R&D, International business development team, QA, QC and Plant for timely submission of Registration, Re-Registration Dossiers, variation to Respective MoH

DECLARATION

I do here by declare that the above information furnished by me are true and valid and will be responsible if any query arises in future during my working.

Shailesh Ailwar

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