Formulation regulatory affairs
3 weeks ago
Role - Formulation Regulatory Affairs Role - US / Canada Market Level - Assistant Manager / Deputy Manager /Associate Manager - US Market Required Education/Exp: Experience Req.: 7 - 12 yrs. Qualification: - M. Pharma / M. Sc. Responsibilities Hands on experience on preparation, review and submission of ANDA/ANDS in US Market, including Modules. Experience and knowledge on life cycle management for the products filed in US market. Comprehensive and up-to-date knowledge on regulatory guidelines/requirements. Providing necessary regulatory inputs to different cross functional teams (including CMO and CDMO projects) during different stages of product development and manufacturing. Responsible to understand the requirements related to US regulatory submissions. Maintaining the necessary regulatory databases concurrently as on when regulatory updates are received. Publishing the necessary regulatory dossiers into e CTD format as per the country requirement. Review of technical (developmental and plant) documentations required for dossier submission. Candidates with relevant exp., kindly share CVs to apply on :- Required skills :- Hands on ANDA/ANDS Filing expertise A stable candidate from Pharma company Should have exp of US Submissions Well versed with regulatory guidelines. Candidates with relevant exp., kindly share CVs to apply on :- Kindly mention below details while sharing CV : Total Exp? Current CTC? Total number of ANDA/ANDS filings? Handling Pre-approval activities or not? Notice Period Ok for working in Bangalore? (5 Days working)
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Regulatory affairs specialist
3 weeks ago
Bangalore, India Biocon Full timeRole - Formulation Regulatory Affairs Role - US / Canada Market Level - Deputy Manager /Associate Manager/ Manager - US Market Required Education/Ex p: Experience Req.: 9 - 14 yrs. Qualification: - M. Pharma / M. Sc. Responsibiliti es: Hands on experience on preparation, review and submission of ANDA/ANDS in US Market, including...
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Biocon | Formulation Regulatory Affairs
4 weeks ago
bangalore, India Biocon Full timeRole - Formulation Regulatory Affairs Role - US / Canada MarketLevel - Assistant Manager / Deputy Manager /Associate Manager - US MarketRequired Education/Exp:Experience Req.: 7 - 12 yrs.Qualification: - M. Pharma / M.Sc.ResponsibilitiesHands on experience on preparation, review and submission of ANDA/ANDS in US Market, including Modules.Experience and...
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Biocon | Regulatory Affairs Specialist
4 days ago
bangalore, India Biocon Full timeRole - Formulation Regulatory Affairs Role - US / Canada MarketLevel - Deputy Manager /Associate Manager/ Manager - US MarketRequired Education/Ex p:Experience Req.: 9 - 14 yrs.Qualification: - M. Pharma / M. Sc.Responsibiliti es:Hands on experience on preparation, review and submission of ANDA/ANDS in US Market, including Modules.Experience and knowledge...
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Regulatory Affairs Specialist
3 weeks ago
Bangalore, India Biocon Full timeRole - Formulation Regulatory Affairs Role - US / Canada Market Level - Deputy Manager /Associate Manager/ Manager - US Market Required Education/Ex p: Experience Req.: 9 - 14 yrs. Qualification: - M. Pharma / M. Sc. Responsibiliti es: Hands on experience on preparation, review and submission of ANDA/ANDS in US Market, including...
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Biocon | Regulatory Affairs Specialist
5 days ago
bangalore, India Biocon Full timeRole - Formulation Regulatory Affairs Role - US / Canada Market Level - Deputy Manager /Associate Manager/ Manager - US Market Required Education/Ex p: Experience Req.: 9 - 14 yrs. Qualification: - M. Pharma / M.Sc. Responsibiliti es: Hands on experience on preparation, review and submission of ANDA/ANDS in US Market, including Modules. Experience and...
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Biocon | Regulatory Affairs Specialist
4 days ago
bangalore, India Biocon Full timeRole - Formulation Regulatory Affairs Role - US / Canada Market Level - Deputy Manager /Associate Manager/ Manager - US Market Required Education/Ex p: Experience Req.: 9 - 14 yrs. Qualification: - M. Pharma / M.Sc. Responsibiliti es: Hands on experience on preparation, review and submission of ANDA/ANDS in US Market, including Modules. Experience and...
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Biocon | Regulatory Affairs Specialist
3 weeks ago
bangalore, India Biocon Full timeRole - Formulation Regulatory Affairs Role - US / Canada MarketLevel - Deputy Manager /Associate Manager/ Manager - US Market Required Education/Exp:Experience Req.: 9 - 14 yrs.Qualification: - M. Pharma / M.Sc.Responsibilities:Hands on experience on preparation, review and submission of ANDA/ANDS in US Market, including Modules.Experience and knowledge on...
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Formulation Regulatory Affairs Specialist
4 months ago
bangalore, India Biocon Full timeKey ResponsibilitiesPreparation, review, and timely submission of ANDA in US market.Deficiency and life cycle management for the products filed in US.Review of technical (developmental and plant) documentations required for dossier submission.Providing necessary regulatory inputs to different cross functional teams (including CMO and CDMO projects) during...
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Formulation regulatory affairs specialist
3 weeks ago
Bangalore, India Biocon Full timeKey Responsibilities Preparation, review, and timely submission of ANDA in US market. Deficiency and life cycle management for the products filed in US. Review of technical (developmental and plant) documentations required for dossier submission. Providing necessary regulatory inputs to different cross functional teams (including CMO and CDMO...
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Formulation Regulatory Affairs Specialist
3 weeks ago
Bangalore, India Biocon Full timeKey Responsibilities Preparation, review, and timely submission of ANDA in US market. Deficiency and life cycle management for the products filed in US. Review of technical (developmental and plant) documentations required for dossier submission. Providing necessary regulatory inputs to different cross functional teams (including CMO and CDMO...
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Formulation Regulatory Affairs Specialist
6 months ago
bangalore, India Biocon Full timeKey Responsibilities Preparation, review, and timely submission of ANDA in US market. Deficiency and life cycle management for the products filed in US. Review of technical (developmental and plant) documentations required for dossier submission. Providing necessary regulatory inputs to different cross functional teams (including CMO and CDMO projects)...
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bangalore, India Biocon Full timeKey ResponsibilitiesPreparation, review, and timely submission of ANDA in US market.Deficiency and life cycle management for the products filed in US.Review of technical (developmental and plant) documentations required for dossier submission.Providing necessary regulatory inputs to different cross functional teams (including CMO and CDMO projects) during...
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Regulatory Affairs Associate
4 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 specialise in market leading technologies that push the...
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Info tech project manager_regulatory affairs
3 months ago
Bangalore, India Biocon Biologics Full timeAt BBL we leverage cutting-edge science, innovative tech platforms and advanced research & development capabilities to lower treatment costs while improving healthcare outcomes. Intentional curiosity and an innate entrepreneurial scientific spirit fuel our strong research pipeline of biosimilar molecules across diabetes, oncology, immunology, and other...
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Regulatory analyst
24 hours ago
Bangalore, India Fluke Corporation Full timeDescription: The Fluke Environmental Compliance Team is responsible for all Fluke global product chemical and environmental regulatory compliance efforts. The focus of the Fluke Chemical and Environmental Compliance is on obtaining product data using various technology tools as well as chemical testing, and vendor engagement. Fluke Regulatory Compliance...
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Regulatory affairs specialist
24 hours ago
Bangalore, India Dozee Full timeOverview : Include dossier preparation, on-time tracking of applications and network with regulatory bodies and bring in compliance. Play an active role in a change environment Supports the ongoing implementation and sustainment of Quality and Regulatory compliance as per local and international rules and regulations. Responsibilities : Plan,...
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Info Tech Project Manager_Regulatory Affairs
4 months ago
bangalore, India Biocon Biologics Full timeAt BBL we leverage cutting-edge science, innovative tech platforms and advanced research & development capabilities to lower treatment costs while improving healthcare outcomes. Intentional curiosity and an innate entrepreneurial scientific spirit fuel our strong research pipeline of biosimilar molecules across diabetes, oncology, immunology, and other...
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Regulatory Specialist
4 months ago
bangalore, India Tag Full timeREGULATORY SPECIALISTAt Tag, we help brands stand out and sell more by delivering impactful content, at speed and scale and across channels & geographies. With over fifty years of production experience for some of the world’s biggest brands, we partner with our clients to create work that is efficient, effective and more importantly tells a story.We...
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Regulatory Analyst
2 weeks ago
Bangalore Urban, India Fluke Corporation Full timeDescription: The Fluke Environmental Compliance Team is responsible for all Fluke global product chemical and environmental regulatory compliance efforts. The focus of the Fluke Chemical and Environmental Compliance is on obtaining product data using various technology tools as well as chemical testing, and vendor engagement. Fluke Regulatory Compliance...
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Regulatory Analyst
2 weeks ago
Bangalore Urban, India Fluke Corporation Full timeDescription: The Fluke Environmental Compliance Team is responsible for all Fluke global product chemical and environmental regulatory compliance efforts. The focus of the Fluke Chemical and Environmental Compliance is on obtaining product data using various technology tools as well as chemical testing, and vendor engagement. Fluke Regulatory Compliance...