Publishing specialist
2 days ago
Key Responsibilities:Strong understanding of e CTD, Nee S, 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, Share Point.Ability to perform end-to-end e CTD 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 ExperienceB. Pharmacy / M. Pharmacy / B. Sc. / M. Sc.Minimum 4 to 8 yearsPreferred Qualifications/ SkillsProficiency in managing Regulatory e CTD Submission for all Global Markets.Good knowledge on e CTD 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
3 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
3 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 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
2 weeks 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
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 (e CTD, Nee S) to global health authorities, ensuring compliance with international regulatory standards.RESPONSIBILITIES:•...
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Publishing specialist
2 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 (e CTD, Nee S) to global health authorities, ensuring compliance with international regulatory standards.RESPONSIBILITIES:•...
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Publishing Specialist
3 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
3 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...
