API Regulatory Affairs
4 days ago
Role - API Regulatory Affairs - DMF Filing/ Compilation (Global market)Level - Assistant Manager/Deputy Manager /Associate Manager Level:-Required Education/Exp :-Experience Req.: 7 yrs. - 15 yrs.Qualification: - M.Sc. / M.PharmaResponsibilities1. Hands on Regulatory Affairs-API /DMF Filing/ DMF Compilation/ Submission/ Customer Communication etc.2. Compilation and submission of DMFs globally for small molecule APIs in eCTD format and in-line with ICH and region specific (EU, US, Canada, Japan, Australia, Brazil, China, South Korea etc.) regulatory guidelines.3. Should have good knowledge of all the regulatory guidelines and API Regulatory processes.4. Compilation of response to queries received from Regulatory Agencies & customers globally and submission of response within the stipulated timeline.5. Review and submission of new DMFs, deficiency responses, amendments, updations to various regulatory agencies.6. Evaluation of change controls and updating to agencies by considering change categories.7. Should have hands-on experience in eCTD softwareCandidates with relevant exp., kindly share CVs to apply on :- rashmi.gupta@biocon.comKindly mention below details while sharing CV :-Total Exp?Current CTC?Total number of DMF filings?Handling which major markets globally ?Notice Period?Ready to work in Bangalore (onsite) ? (5 Days working)
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API Regulatory Affairs
20 hours ago
Bangalore, India Biocon Ltd Full timeRole - API Regulatory Affairs - DMF Filing/ Compilation (Global market) Level - Assistant Manager/Deputy Manager /Associate Manager Level:- Required Education/Exp :- Experience Req.: 7 yrs. - 15 yrs. Qualification: - M.Sc. / M.Pharma Responsibilities 1. Hands on Regulatory Affairs-API /DMF Filing/ DMF Compilation/ Submission/ Customer Communication etc. 2....
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Regulatory Affairs Specialist
2 weeks ago
bangalore, India Concept Medical Full timeAbout Us:Concept Medical is at the forefront of developing and manufacturing innovative medical devices for interventional cardiology and radiology. Our commitment to excellence in healthcare and patient outcomes drives us to provide the best-in-class stents and balloon catheters. With a growing presence in the global market, we are expanding our team in the...
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Regulatory Affairs Specialist
2 weeks ago
bangalore, India Dr. Reddy's Laboratories Full timeJob SummaryWe are seeking a detail-oriented Specialist in Regulatory Affairs primarily focusing on Oligonucleotides typically has a role that involves ensuring compliance with regulatory requirements for these products. Responsibilities include managing chemistry, manufacturing, and controls (CMC) documentation for DMF submission, addressing deficiency...
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Regulatory Affairs Executive
2 days ago
bangalore, India Halma plc Full timeAbout Halma:Halma is a global group of life-saving technology companies, driven by a clear purpose. We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs in India, China, Brazil, and the US.Our diverse group of nearly 50 global companies specialize in market leading technologies that push the...
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Scientific and Regulatory Affairs Consultant
20 hours ago
Bangalore, India Biocon Full timeRole - Formulation Regulatory Affairs - for Peptide products or Injectables Required Education/Ex p: Experience Req.: 8 - 12 yrs. Key Role- Formulation Regulatory Affairs for Peptide products or Injectables Drafting controlled correspondences, pre-development meetings and scientific advices for seeking regulatory feedback on various topics from different...
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Regulatory Affairs Executive
3 weeks ago
bangalore, India Halma plc Full timeAbout Halma: Halma is a global group of life-saving technology companies, driven by a clear purpose. We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs in India, China, Brazil, and the US. Our diverse group of nearly 50 global companies specialize in market leading technologies that push the...
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Regulatory Affairs Executive
3 weeks ago
Bangalore, India Halma plc Full timeAbout Halma: Halma is a global group of life-saving technology companies, driven by a clear purpose. We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs in India, China, Brazil, and the US. Our diverse group of nearly 50 global companies specialize in market leading technologies that push the...
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Regulatory Affairs Executive
21 hours ago
bangalore, India Halma plc Full timeAbout Halma: Halma is a global group of life-saving technology companies, driven by a clear purpose. We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs in India, China, Brazil, and the US. Our diverse group of nearly 50 global companies specialize in market leading technologies that push the...
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Regulatory Affairs Manager
1 week ago
bangalore, India Biocon Biologics Full timeKey Responsibilities: 1. Regulatory Strategy & Planning • Develop and implement regional regulatory strategies for biosimilar product registrations in the Middle East, North Africa, CIS, and Non-EEA countries. • Ensure alignment with global regulatory strategy and business priorities. • Conduct regulatory risk assessment and provide mitigation...
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Regulatory Affairs Manager
1 week ago
bangalore, India Biocon Biologics Full timeKey Responsibilities: 1. Regulatory Strategy & Planning • Develop and implement regional regulatory strategies for biosimilar product registrations in the Middle East, North Africa, CIS, and Non-EEA countries. • Ensure alignment with global regulatory strategy and business priorities. • Conduct regulatory risk assessment and provide mitigation...