Yogeshwar Chavan
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Yogeshwar Chavan Email & Phone Number

Senior Manager Regulatory Affairs at PharmaLex
Location: Mumbai, Maharashtra, India 8 work roles 1 school
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Current company
Role
Senior Manager Regulatory Affairs
Location
Mumbai, Maharashtra, India

Who is Yogeshwar Chavan? Overview

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Quick answer

Yogeshwar Chavan is listed as Senior Manager Regulatory Affairs at PharmaLex, based in Mumbai, Maharashtra, India. AeroLeads shows a matched LinkedIn profile for Yogeshwar Chavan.

Yogeshwar Chavan previously worked as Regulatory Affairs Manager at Genpact and Regulatory Affairs Assistant Manager at Genpact. Yogeshwar Chavan holds Bachelor Of Pharmacy - Bpharm, Pharmacy from All India Shivaji Memorial Societys College Of Pharmacy, Pune.

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PharmaLex

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Profile bio

About Yogeshwar Chavan

Highly experienced professional with 17+ years of Regulatory Affairs exposure. Majorly experienced in EU-Post Approvals. • Hands on Experience in MRP/DCP/Nationals/ RUP + Worksharing Procedures• Expertise in - Module1 ,2 and 3 • Handled Quality as well as safety variations/Safety signals/CCDS updates/Artwork Changes/PSUR

Listed skills include Regulatory Affairs, Regulatory Submissions, Regulatory Requirements, Ectd, and 2 others.

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Yogeshwar Chavan's current company

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PharmaLex
Pharmalex
Senior Manager Regulatory Affairs
Mumbai, MH, IN
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8 roles

Yogeshwar Chavan work experience

A career timeline built from the work history available for this profile.

Senior Manager Regulatory Affairs

Mumbai, Mh, In

Senior Manager Regulatory Affairs

Current

Mumbai, Maharashtra, India

EU Regulatory Affairs

Aug 2024 - Present

Regulatory Affairs Manager

Mumbai, Maharashtra, India

Majorly experienced in EU-Post Approvals - Project Manager• Hands on Experience in MRP/DCP/Nationals/ RUP + Worksharing Procedures• Expertise in - Module1 ,2 and 3 • Handled Quality as well as safety variations/Safety signals/CCDS changes (SmPC, PIL Changes)/PSUR Submissions: Authoring, review, HA Fees arrangements, RFI Response and CESP Submissions.• Review of mock-ups as well as Commercial Artworks as part of change implementation.• RFIs/Deficiency Response • Change Control-Regulatory evaluation and strategy. • Guideline Expertise: Deliver all submissions as per guideline expectations and company standards.• Product Lifecycle Management. • System Knowledge /Expertise - Track wise – Change control management - ESKO-SAAS- Artwork Project Management - EQMS- RA Training sessions - GDMS-Dossier management. - Veeva vault- Authoring, review, publishing, maintenance of e-ctd lifecycle and submission planning and record updates in system (Veeva). - Keeping and maintaining internal submission/authoring -trackers, Submission planner, Publishing planner etc.

Oct 2021 - Aug 2024

Regulatory Affairs Assistant Manager

Mumbai Area, India

EU-Post Approval activities-CMC & Safety Variations. Artwork Review & Approval for change implementation. (PIL, Cartons, Foils etc)

Apr 2016 - Oct 2021

Regulatory Affairs Executive

Mumbai, Maharashtra, India

ROW markets - Renewals. Biological Products- Post Approval Activities (US -PAS, CBE 30 etc )Clinical Trial Label Review of Investigational Products.

May 2012 - Apr 2016

Regulatory Affairs

US /EU - Post Approval

Aug 2008 - May 2012

Regulatory Affairs

Dossier compilations for African, South East Asian, Middle east countries ,Data review n Communication/co-ordination with All departments

Jul 2007 - Aug 2008

Adl –Method Development-Officer

Mumbai, Maharashtra, India

ADL Analytical experience with Method validation and complete release testing of Tablets /Capsules of RND batches. (Instrumental Knowledge of QC testing instruments/HPLC)

Feb 2007 - Jul 2007
1 education record

Yogeshwar Chavan education

FAQ

Frequently asked questions about Yogeshwar Chavan

Quick answers generated from the profile data available on this page.

What company does Yogeshwar Chavan work for?

Yogeshwar Chavan works for PharmaLex.

What is Yogeshwar Chavan's role at PharmaLex?

Yogeshwar Chavan is listed as Senior Manager Regulatory Affairs at PharmaLex.

Where is Yogeshwar Chavan based?

Yogeshwar Chavan is based in Mumbai, Maharashtra, India while working with PharmaLex.

What companies has Yogeshwar Chavan worked for?

Yogeshwar Chavan has worked for Pharmalex, Genpact, Cipla Ltd., Meyer Organics Pvt. Ltd., and Ajanta Pharma Ltd.

How can I contact Yogeshwar Chavan?

You can use AeroLeads to view verified contact signals for Yogeshwar Chavan at PharmaLex, including work email, phone, and LinkedIn data when available.

What schools did Yogeshwar Chavan attend?

Yogeshwar Chavan holds Bachelor Of Pharmacy - Bpharm, Pharmacy from All India Shivaji Memorial Societys College Of Pharmacy, Pune.

What skills is Yogeshwar Chavan known for?

Yogeshwar Chavan is listed with skills including Regulatory Affairs, Regulatory Submissions, Regulatory Requirements, Ectd, Regulations, and Pharmaceutics.

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