Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. APDC (TEVA Global Centre, Chennai) is high tech lab approved by USFDA & MHRA providing stability service for our global Teva network. Join TEVA Stability Team to learn and enrich your career in Quality.
Regulatory Publishing Associate I
Qualification & Experience : • B.Pharm / M.Pharm / Master of Life Sciences.
• 2-3.5 years of experience required (preferred-Regulatory publishing experience in EU and US market)
Specifications
• Exposure to handle submission publishing.
• Hands to expertise in EU & US submissions frorr pre-approval to post approval activities.
• Maintain working knowledge of publishing standards as per agency standards.
• Must be aware of technical systems like Global Insight, Veeva Vault, ISI Toolbox, Adobe Acrobat, Lorenz/EURS Validator.
• Knowledge of ICH and eCTD related specifications/guidelines governing regulatory submissions (eCTD, NeeS, Paper)
Regulatory Publishing Associate II
Qualification & Experience : • B.Pharm / M.Pharm / Master of Life Sciences.
• 4-7 years of experience required (preferred-Regulatory publishing experience in EU and US market)
Specifications
• Exposure to handle submission publishing.
• Hands to expertise in EU & US submissions frorr pre-approval to post approval activities.
• Maintain working knowledge of publishing standards as per agency standards.
• Must be aware of technical systems like Global Insight, Veeva Vault, ISI Toolbox, Adobe Acrobat, Lorenz/EURS Validator.
• Knowledge of ICH and eCTD related specifications/guidelines governing regulatory submissions (eCTD, NeeS, Paper)
Regulatory Affairs Associate lll-US Labelling
Qualification & Experience : • M.Sc / M.Pharm / B.Pharm / B.Sc.
• 6 years of experience required in Regulatory affairs with US labelling.
Specifications
• Subject matter expert in US labelling.
• Preparing & reviewing labelling documents.
• Electronic proofreading (TVT)
• Submitting RLD updates, safety updates, annual reportable change.
• SPL preparation.
Regulatory Affairs Associate l-US Labelling
Qualification & Experience : • M.Sc./ M.Pharm / B.Pharm / B.Sc.
• 1-4 years of experience required in Regulatory affairs
• Minimum 1-2 years of relevant experience in US labelling.
Specifications
• Experience in US labelling.
• Preparing labelling documents.
• Electronic proofreading (TVT)
• Submitting RLD updates, safety updates, annual reportable change.
• SPL preparation.
Regulatory Affairs Associate l-US Labelling & AMT Proofreading
Qualification & Experience : • M.Sc./ M.Pharm / B.Pharm / B.Sc.
• 1-4 years of experience required in Regulatory affairs
• Minimum 1-2 years of relevant experience in US labelling.
Specifications
• Experience in US labelling.
• Preparing labelling documents.
• Electronic proofreading (TVT)
• Submitting RLD updates, safety updates, annual reportable change.
• SPL preparation.
Job Location : Seawoods, Navi Mumbai
Walk in Interview
Date & Day : Saturday, 1st July
Time : 10 am to 3 pm
Venue : 9th floor, E Wing, Tower II, Grand Central, Sector 40, Seawoods-Navi Mumbai
Interested candidates may also email their CVs at : Ankita.Sonawane@teva.co.in
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