Yogeshwar Chavan Email & Phone Number
Who is Yogeshwar Chavan? Overview
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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.
Email format at PharmaLex
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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.
Yogeshwar Chavan's current company
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Yogeshwar Chavan work experience
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Regulatory Affairs Manager
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.
Regulatory Affairs Assistant Manager
EU-Post Approval activities-CMC & Safety Variations. Artwork Review & Approval for change implementation. (PIL, Cartons, Foils etc)
Regulatory Affairs Executive
ROW markets - Renewals. Biological Products- Post Approval Activities (US -PAS, CBE 30 etc )Clinical Trial Label Review of Investigational Products.
Regulatory Affairs
Dossier compilations for African, South East Asian, Middle east countries ,Data review n Communication/co-ordination with All departments
Adl –Method Development-Officer
ADL Analytical experience with Method validation and complete release testing of Tablets /Capsules of RND batches. (Instrumental Knowledge of QC testing instruments/HPLC)
Yogeshwar Chavan education
Frequently asked questions about Yogeshwar Chavan
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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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