Current jobs related to Regulatory Affairs CMC - Hyderabad, Telangana - Vipsa Talent Solutions

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  Regulatory Affairs CMC Manager

  3 weeks ago

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  Hyderabad, Telangana, India Amgen Inc Full time

  Job DescriptionLet's do this. Let's change the world. Amgen is searching for a Manager for the Submission Process, Planning, and Management (SPPM) team within Global CMC & Device Regulatory Affairs in Amgen India (AIN). The mission of SPPM is to support productivity across the organization and stakeholders by:Driving continuous improvement of processes and...

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  Regulatory Affairs CMC Associate

  2 weeks ago

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  Hyderabad, Telangana, India Ztek Consulting Full time

  Job Description – Regulatory Affairs CMC Associate (US Market)We are seeking a Regulatory Affairs Associate to support US FDA submissions and lifecycle management activities.Key Responsibilities:- Prepare, review, and compile regulatory submissions (ANDAs, NDAs, supplements, amendments, deficiency responses, annual reports, PADER) in eCTD format.- Maintain...

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  Regulatory Affairs Specialist

  2 weeks ago

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  Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 9,00,000 - ₹ 12,00,000

  Job Title:Regulatory Affairs Specialist - CMCJob Description:This position involves supporting submissions to regulatory authorities and managing the lifecycle of products. We are seeking a highly skilled Regulatory Affairs Specialist to join our team.Key Responsibilities:Prepare, review, and compile high-quality regulatory submissions in electronic format,...

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  CMC Regulatory Affairs

  1 day ago

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  Hyderabad, Telangana, India Freyr Solutions Full time ₹ 20,00,000 - ₹ 25,00,000 per year

  Primary Responsibilities:Responsible for finalizing the CMC regulatory strategies for assigned products (Biological products) and provide support to execute tasks independently in accordance with global regulations and guidance procedures.Serve as the CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones for...

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  Regulatory Affairs CMC Associate

  2 weeks ago

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  Hyderabad, Telangana, India Ztek Consulting Full time

  Job Description – Regulatory Affairs CMC Associate (US Market)We are seeking a Regulatory Affairs Associate to support US FDA submissions and lifecycle management activities.Key Responsibilities:Prepare, review, and compile regulatory submissions (ANDAs, NDAs, supplements, amendments, deficiency responses, annual reports, PADER) in eCTD format.Maintain...

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  Regulatory Affairs Specialist

  2 weeks ago

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  Hyderabad, Telangana, India beBeeCompliance Full time ₹ 1,80,00,000 - ₹ 2,50,00,000

  Job Title:Regulatory Affairs Specialist - CMC StrategyJob Summary:We are seeking a skilled professional to develop and execute CMC regulatory strategies for assigned products, ensuring global compliance.Key Responsibilities:Develop and execute comprehensive CMC regulatory strategies for assigned products across the product lifecycle.Lead the development,...

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  Regulatory Affairs Manager – Cmc

  2 weeks ago

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  Hyderabad, Telangana, India Vueverse. Full time

  Key Responsibilities: Lead and manage CMC regulatory activities for USFDA submissions including ANDA preparation, review, and filing.Oversee compilation and submission of Annual Reports, amendments, and deficiency responses.Interface with cross-functional teams including Quality Assurance, Production, and R&D to gather required documentation and data.Review...

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  Regulatory Affairs Specialist

  2 weeks ago

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  Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 25,00,000

  Job Title: Regulatory Affairs SpecialistAbout This RoleWe are seeking a detail-oriented professional to support end-to-end submissions for global markets, focusing on regulatory affairs - CMC (Chemical, Manufacturing and Controls) aspects.Key ResponsibilitiesPreparing Variation documentsEvaluating post-approval CMC changes in compliance with global...

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  Regulatory Affairs _ US Market

  5 days ago

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  Hyderabad, Telangana, India BVR People Consulting Full time ₹ 9,00,000 - ₹ 12,00,000 per year

  GreetingsWe are seeking experienced professionals in Regulatory Affairs US Market (CMC, Module 3) with expertise in Formulation, for our Hyderabad-based R&D Centre.Regulatory Affairs US Market (CMC) with strong exposure to ANDA/NDA submissions and post-approval changes.Key Responsibilities:Hands-on experience in US Regulatory Affairs for ANDA & NDA (Approved...

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  Senior Regulatory Affairs Professional

  2 weeks ago

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  Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 20,00,000 - ₹ 25,50,000

  Regulatory Affairs Associate Manager Job DescriptionWe are seeking a highly skilled Regulatory Affairs Associate Manager to lead our team in Hyderabad, India. The successful candidate will be responsible for regulatory activities related to chemistry, manufacturing, and control (CMC).Main Responsibilities:Author high-quality global CMC documentation for...