Submission Publisher
4 weeks ago
Job Description Roles & Responsibilities:- - Utilize current electronic document management and publishing tools to prepare submission-ready Regulatory components and assemble, publish, and dispatch dossiers according to regulatory requirements for paper and electronic submissions with limited supervision - Submission Dossiers that may be periodic (e.g.: safety reports) or minor amendments (e.g.: IND Amendment, DMF Amendment, CMC Update as appropriate to level, etc) or otherwise not major applications but in support of pending approvals or lifecycle commitments for marketed products (e.g.: meeting packages, responses as appropriate, Advertising and Promotion Submissions, routine labeling updates as appropriate, etc.) - Global Regulatory knowledge of product registration procedures covering IND, NDAs, CTAs, BLA, IMPDs, MAAs for various countries including regulated markets like US, EU, Canada and Australia-NZ - Support regulatory submissions publishing for EDMF, COS/CEP for Drug substance related filing and regulatory submissions publishing in MRP, DCP, CP and National filing for the EU - Reviews and maintains regulatory database comprising existing and new regulations pertaining to submission requirements for the region - QC submission dossiers or parts of submission dossier output of low-tomoderate and moderate-to-high complexities as assigned.
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Publishing Specialist
2 weeks ago
Bengaluru, India Biocon Biologics Full timeKey Responsibilities:Strong understanding of eCTD, NeeS, and ICH guidelines.Familiarity with Regulatory systems and Publishing tools.Use publishing tools such as: Lorenz Docubridge, Ectd Validator, ISI Toolbox, Adobe Acrobat, MS Excel, SharePoint.Ability to perform end-to-end eCTD submission process, including Document level Publishing and Dossier...
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Publishing Specialist
2 weeks ago
Bengaluru, India Biocon Biologics Full timeKey Responsibilities:Strong understanding of eCTD, NeeS, and ICH guidelines.Familiarity with Regulatory systems and Publishing tools.Use publishing tools such as: Lorenz Docubridge, Ectd Validator, ISI Toolbox, Adobe Acrobat, MS Excel, SharePoint.Ability to perform end-to-end eCTD submission process, including Document level Publishing and Dossier...
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Publishing Specialist
1 week ago
Bengaluru, India Biocon Biologics Full timeKey Responsibilities:Strong understanding of eCTD, NeeS, and ICH guidelines.Familiarity with Regulatory systems and Publishing tools.Use publishing tools such as: Lorenz Docubridge, Ectd Validator, ISI Toolbox, Adobe Acrobat, MS Excel, SharePoint.Ability to perform end-to-end eCTD submission process, including Document level Publishing and Dossier...
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Publishing Specialist
7 days ago
Bengaluru, India Biocon Biologics Full timeKey Responsibilities:Strong understanding of eCTD, NeeS, and ICH guidelines.Familiarity with Regulatory systems and Publishing tools.Use publishing tools such as: Lorenz Docubridge, Ectd Validator, ISI Toolbox, Adobe Acrobat, MS Excel, SharePoint.Ability to perform end-to-end eCTD submission process, including Document level Publishing and Dossier...
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Publishing Specialist
6 days ago
Bengaluru, India Biocon Biologics Full timeKey Responsibilities:Strong understanding of eCTD, NeeS, and ICH guidelines.Familiarity with Regulatory systems and Publishing tools.Use publishing tools such as: Lorenz Docubridge, Ectd Validator, ISI Toolbox, Adobe Acrobat, MS Excel, SharePoint.Ability to perform end-to-end eCTD submission process, including Document level Publishing and Dossier...
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Publishing Specialist
2 weeks ago
Bengaluru, India Biocon Biologics Full timeJOB DESCRIPTIONWe are seeking a detail-oriented and proactive Regulatory Affairs Associate to join our Regulatory Publishing team. In this role, you will be responsible for preparing and submitting high-quality electronic submissions (eCTD, NeeS) to global health authorities, ensuring compliance with international regulatory standards.RESPONSIBILITIES:•...
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Publishing Specialist
2 weeks ago
Bengaluru, India Biocon Biologics Full timeJOB DESCRIPTIONWe are seeking a detail-oriented and proactive Regulatory Affairs Associate to join our Regulatory Publishing team. In this role, you will be responsible for preparing and submitting high-quality electronic submissions (eCTD, NeeS) to global health authorities, ensuring compliance with international regulatory standards.RESPONSIBILITIES:•...
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Publishing Specialist
2 weeks ago
Bengaluru, India Biocon Biologics Full timeJOB DESCRIPTIONWe are seeking a detail-oriented and proactive Regulatory Affairs Associate to join our Regulatory Publishing team. In this role, you will be responsible for preparing and submitting high-quality electronic submissions (eCTD, NeeS) to global health authorities, ensuring compliance with international regulatory standards.RESPONSIBILITIES:•...
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Publishing Specialist
1 week ago
Bengaluru, India Biocon Biologics Full timeJOB DESCRIPTION We are seeking a detail-oriented and proactive Regulatory Affairs Associate to join our Regulatory Publishing team. In this role, you will be responsible for preparing and submitting high-quality electronic submissions (eCTD, NeeS) to global health authorities, ensuring compliance with international regulatory standards. RESPONSIBILITIES: •...
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Publishing Specialist
1 week ago
Bengaluru, India Biocon Biologics Full timeJOB DESCRIPTION We are seeking a detail-oriented and proactive Regulatory Affairs Associate to join our Regulatory Publishing team. In this role, you will be responsible for preparing and submitting high-quality electronic submissions (eCTD, NeeS) to global health authorities, ensuring compliance with international regulatory standards. RESPONSIBILITIES: •...
