Intern - Ectd Publishing

5 days ago

Bengaluru Karnataka, India Lilly Full time

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

**Manage submissions**
- Plan submission workload by reviewing/monitoring RIM for planned documents for registration submissions.
- Partner with the Global Regulatory Associate and Regional Submission Associate to retrieve, publish, and submit
- Modules 1-5 reports/documents and combine files into electronic submissions (eCTD) and/or non-eCTD submissions according to the master table of contents or Content Plan for the dossier.
- Coordinate global registration activities and provide the necessary documentation to affiliates for registration of products in global countries

**Submit and archive submissions**
- Submit and archive submitted submissions, assuring all metadata fields are complete in RIM.
- Manage FDA Web trader account to enable submissions via electronic gateway.
- Assure all appropriate metadata fields are completed when archiving in electronic filing system (RIM).
- Assure accurate entry for future retrieval of submissions if/when requested

**Build on high level of expertise in electronic publishing**
- Achieve a high level of technical and practical proficiency with eCTD XPress, Adobe
- Acrobat, Submission Validation software (Lorenz), ISIToolbox.
- Successfully complete the formal training modules.
- Stay up to date on system and tool upgrades that impact publishing.

**Build technical and quality expertise**
- Understand changes to Regulatory Guidance and Requirements and advise RDE
- Management as to their potential impact on Publishing.
- Keep current on latest quality improvement methods.
- Ensure best practices through partnership with Regulatory Quality

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

WeAreLilly

  • Publishing Specialist

    3 days ago

    Bengaluru, India Biocon Biologics Full time

    JOB 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:•...

  • Publishing Specialist

    4 days ago

    Bengaluru, India Biocon Biologics Full time

    JOB 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:•...

  • Publishing Specialist

    4 days ago

    Bengaluru, India Biocon Biologics Full time

    JOB 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:•...

  • Publishing Specialist

    15 hours ago

    Bengaluru, India Biocon Biologics Full time

    JOB 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: •...

  • Publishing Specialist

    8 hours ago

    Bengaluru, India Biocon Biologics Full time

    JOB 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: •...

  • Publishing Specialist

    2 days ago

    Bengaluru, India Biocon Biologics Full time

    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...

  • Publishing Specialist

    4 days ago

    Bengaluru, India Biocon Biologics Full time

    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...

  • Publishing Specialist

    16 hours ago

    Bengaluru, India Biocon Biologics Full time

    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...

  • Publishing Specialist

    2 days ago

    Bengaluru, India Biocon Biologics Full time

    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...

  • Publishing Specialist

    4 days ago

    Bengaluru, India Biocon Biologics Full time

    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...