Regulatory labelling manager
5 days ago
Labelling Manager Bangalore, India Job Description: Responsible for Creating Labeling Strategy for the health authority interactions and handling HA or Country Organization (CO) labeling queries for assigned program/ products. Ensure Artwork Management for Initial Submission / Commercial Launch activities in coordination with CFT team. Responsible for Promotional Material Review and participate in CFT meetings representing Regulatory on strategic decisions by ensuring no misleading information. Responsible to Coordinate with External Vendor to ensure Translations documents are prepared / reviewed to support Global Regulatory Submissions. Responsible for SPL Preparation for Initial Submission / Labelling Response and Drug Listing for Approved Products as per business/agency timeline. Change management process of CCDS, Non-CCDS and Annual reportable labelling changes. Analysis of competitor information (e. G., labels, approval packages) for regulatory policy projects and/or labelling projects Escalate, notify, and resolve any issues that may impact final labelling submission. Responsible for maintaining internal tracker for CCDS, Non-CCDS and Annual reportable labelling changes and submissions. Responsible for managing Global Labelling Impact Assessment (RLD update / Safety Information Update). Manage Labelling Team members and direct them to follow as per business process and ensure first time right quality. Required/Qualifications: B. Pharmacy / M. Pharmacy / B. Sc. / M. Sc. A minimum of 7 years of regulatory labelling experience, especially EU labelling. Artwork management, commercial launch & SPL is a mandate.
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Regulatory Labelling Manager
3 weeks ago
Bangalore City, India Biocon Biologics Full timeLabelling ManagerBangalore, IndiaJob Description:Responsible for Creating Labeling Strategy for the health authority interactions and handling HA or Country Organization (CO) labeling queries for assigned program/ products.Ensure Artwork Management for Initial Submission / Commercial Launch activities in coordination with CFT team.Responsible for Promotional...
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Regulatory Labelling Manager
3 weeks ago
bangalore, India Biocon Biologics Full timeLabelling ManagerBangalore, IndiaJob Description:Responsible for Creating Labeling Strategy for the health authority interactions and handling HA or Country Organization (CO) labeling queries for assigned program/ products.Ensure Artwork Management for Initial Submission / Commercial Launch activities in coordination with CFT team.Responsible for Promotional...
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Regulatory Labelling Manager
3 weeks ago
Bangalore, India Biocon Biologics Full timeLabelling Manager Bangalore, India Job Description: Responsible for Creating Labeling Strategy for the health authority interactions and handling HA or Country Organization (CO) labeling queries for assigned program/ products. Ensure Artwork Management for Initial Submission / Commercial Launch activities in coordination with CFT team. Responsible...
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Regulatory Labelling Manager
4 days ago
bangalore, India Biocon Biologics Full timeLabelling ManagerBangalore, IndiaJob Description:- Responsible for Creating Labeling Strategy for the health authority interactions and handling HA or Country Organization (CO) labeling queries for assigned program/ products.- Ensure Artwork Management for Initial Submission / Commercial Launch activities in coordination with CFT team.- Responsible for...
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Regulatory Labelling Manager
3 weeks ago
bangalore, India Biocon Biologics Full timeLabelling Manager Bangalore, India Job Description: Responsible for Creating Labeling Strategy for the health authority interactions and handling HA or Country Organization (CO) labeling queries for assigned program/ products. Ensure Artwork Management for Initial Submission / Commercial Launch activities in coordination with CFT team. Responsible for...
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Regulatory Labelling Manager
3 weeks ago
bangalore, India Biocon Biologics Full timeLabelling ManagerBangalore, IndiaJob Description:Responsible for Creating Labeling Strategy for the health authority interactions and handling HA or Country Organization (CO) labeling queries for assigned program/ products.Ensure Artwork Management for Initial Submission / Commercial Launch activities in coordination with CFT team.Responsible for Promotional...
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Regulatory Affairs Manager I
5 months ago
Bangalore, India AstraZeneca Full timeJob Title: Regulatory Affairs Manager I Career Level - D Introduction to role: The Regulatory Affairs Manager I is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables, including delivery as an individual contributor, if required. The...
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Manager Global Regulatory Affairs
3 weeks ago
Bangalore City, India Biocon Biologics Full timeAssistant ManagerGlobal Regulatory AffairsBangalore, IndiaJob Description:Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products for emerging markets.Biosimilars or injectables experience is mandatory for this role.Responsible for:Development and Implementation of...
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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 specialise in market leading technologies that push the...
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Manager - Clinical Regulatory
5 months ago
Bangalore, India AstraZeneca Full timeJOB TITLE : - CLINICAL REGULATORY CAREER LEVEL: D Lead the way for a new breed of solutions-oriented Regulators Champion a new approach to Regulatory that supports quick decision-making and balanced risk-taking. Curious enterprise-thinkers we proactively take a strategic approach earlier in the product lifecycle to get involved in shaping drug...
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Regulatory Affairs Executive
2 months 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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Regulatory Affairs Manager I/II
5 months ago
Bangalore, India AstraZeneca Full timeJOB TITLE: Regulatory Affairs Manager I/II CAREER LEVEL: D Lead the way for a new breed of solutions-oriented Regulators Champion a new approach to Regulatory that supports quick decision-making and balanced risk-taking. Curious enterprise-thinkers we proactively take a strategic approach earlier in the product lifecycle to get involved in shaping...
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Lead Regulatory Affairs
2 months 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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Formulation Regulatory Affairs
3 weeks ago
Bangalore City, India Biocon Full timeRole - Formulation Regulatory Affairs Role - US / Canada MarketLevel - Senior Executive/ Assistant Manager / Deputy Manager - US Market Required Education/Exp: Experience Req.: 3 - 10 yrs.Qualification: - M.Sc. / M. Pharma.ResponsibilitiesHands on experience on preparation, review and submission of ANDA/ANDS in US Market, including Modules.Experience and...
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Manager global regulatory affairs
3 weeks ago
Bangalore, India Biocon Biologics Full timeAssistant Manager Global Regulatory Affairs Bangalore, India Job Description: Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products for emerging markets. Biosimilars or injectables experience is mandatory for this role . Responsible for : Development and...
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Manager Global Regulatory Affairs
3 weeks ago
bangalore, India Biocon Biologics Full timeAssistant ManagerGlobal Regulatory AffairsBangalore, IndiaJob Description:Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products for emerging markets.Biosimilars or injectables experience is mandatory for this role.Responsible for:Development and Implementation of...
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Manager Global Regulatory Affairs
3 weeks ago
bangalore, India Biocon Biologics Full timeAssistant ManagerGlobal Regulatory AffairsBangalore, IndiaJob Description:Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products for emerging markets.Biosimilars or injectables experience is mandatory for this role.Responsible for:Development and Implementation of...
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Manager global regulatory affairs
3 weeks ago
Bangalore, India Biocon Biologics Full timeRegulatory Affairs Manager Bangalore, India Job Description: Hands on experience on drug substance manufacturing process, designing and executing process characterization studies (upstream, downstream, formulation) as well as process comparability for biologics (monoclonal antibodies/growth factors/hormones) Accountable for development and execution of...
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Manager Global Regulatory Affairs
4 days ago
bangalore, India Biocon Biologics Full timeRegulatory Affairs ManagerBangalore, IndiaJob Description:Hands on experience on drug substance manufacturing process, designing and executing process characterization studies (upstream, downstream, formulation) as well as process comparability for biologics (monoclonal antibodies/growth factors/hormones)Accountable for development and execution of CMC...
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Associate Director, Clinical Regulatory Writing
5 months ago
Bangalore, India AstraZeneca Full timeAt AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance...