Publishing Specialist
4 days ago
Key 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 compilation, and dispatch of submissions to respective Health Authorities (Developed and ROW Markets)- Manage lifecycle submissions including variations, amendments, and renewals.- Perform document-level publishing, hyperlinking, bookmarking, and validation.- Conduct quality control checks to ensure submission readiness.- Collaborate with cross-functional teams including Regulatory Affairs, CMC, and Clinical.- Stay updated with global regulatory guidelines (ICH, FDA, EMA).- Detail-oriented with a collaborative mindset.- Minimum Qualifications and Experience- B. Pharmacy / M. Pharmacy / B.Sc. / M.Sc.- Minimum 4 to 8 years- Preferred Qualifications/ Skills- Proficiency in managing Regulatory eCTD Submission for all Global Markets.- Good knowledge on eCTD Guidance and understanding validation criteria requirement.- Strong communication and interpersonal skills.- Experience with electronic submission (New Development Product Filings / LCM).- Strong project management skills, with the ability to manage multiple projects and deadlines simultaneously.- High level of attention to detail and accuracy in document level publishing and submission compilation/validation.- Ability to work collaboratively in a cross-functional team environment.- Proficiency in using regulatory databases, information management systems, and other relevant software tools.- Commitment to staying updated on regulatory changes and advancements in the field.
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Publishing Specialist
4 days 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
4 days 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
3 days 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
14 hours 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
7 hours 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
4 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 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
15 hours 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
4 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...
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Publishing Specialist
3 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...
