Regulatory Publishing Specialist

4 weeks ago


Bengaluru, Karnataka, India Elanco Full time

At Elanco, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets.

We pride ourselves on fostering a diverse and inclusive work environment, where diversity is the driving force behind innovation, creativity, and overall business success.

As a Regulatory Publishing Specialist, you will work with multiple groups within the Global Regulatory and R & D Organization to assist with publishing needs, implement and manage processes and systems for Regulatory Publishing.

You will develop and maintain positive working relationships with multiple geographies and functional areas, utilizing all required systems that support activities related to regulatory publishing and archiving.

Key Responsibilities:

  • Basic document level publishing knowledge experience.
  • Basic understanding of electronic publishing terminologies as applicable to various regulatory requirements.
  • Understanding and basic experience in creating and maintaining virtual documents, integrating TIF images, hyperlinking, bookmarking, and full text indexing.
  • Supports document management processes and systems and have a thorough understanding of document management tools to maintain proper records and ensure adequate controls.
  • Proficiency in using Veeva Clinial Platform.
  • Understands the details of the global publishing processes and the interdependencies of systems and tools to support the processes.
  • Interacts with various colleagues in global and affiliate roles to meet their publishing needs.
  • Works closely with the Scientific writing and document publishing Team Leader in prioritizing publishing projects to ensure on time delivery & distribution of all documents within the defined timelines.
  • Maintains a positive business collaborations and partnerships.
  • Support study protocols, writing study reports, manuscripts or other documents as needed. The ability to write clear, concise, and accurate scientific documents tailored for health authority submission for a regulatory purpose.
  • Proficiency in Microsoft Word, Adobe Acrobat, and Toolbox.

Requirements:

  • Master's degree in (M Pharm or other life sciences)
  • 3 to 5 years experience in the relevant field
  • Prior experience in the relevant field would be preferred

Preferred Skills:

  • Strong communication skills, both written and oral.
  • Ability to positively interact with multiple geographies, cultures and functional areas.
  • Self-motivated, takes initiative.
  • Timeline driven.
  • Attention to detail.
  • Quality and customer focused mindset.


  • Bengaluru, Karnataka, India Elanco Full time

    At Elanco, we foster a collaborative and inclusive work environment that values diversity and champions innovation.We're seeking a skilled Regulatory Publishing Specialist to join our team.As a Regulatory Publishing Specialist, you will work closely with our Global Regulatory and R&D Organization to publish documents, manage processes, and develop positive...


  • Bengaluru, Karnataka, India Elanco Full time

    At Elanco, we are committed to innovation and delivering products and services to prevent and treat disease in farm animals and pets.As a global leader in animal health, our vision is to advance the health of animals, people, the planet, and our enterprise.As Regulatory Publishing Specialist, you will be part of a company that values diversity, inclusivity,...


  • Bengaluru, Karnataka, India Lilly Full time

    We're seeking a highly skilled Regulatory Publishing Specialist to join our team at Lilly.Key Responsibilities:• Manage submissions, preparing cover letters and forms for regional review and approval.• Plan submission workload by reviewing the RDE RIM or Share Point Calendar for planned documents.• Partner with the Regulatory Associate to retrieve,...


  • Bengaluru, Karnataka, India Lilly Full time

    We're seeking a skilled Regulatory Publishing Specialist to join our team at Lilly.Key Responsibilities: Manage submissions, including preparing submission cover letters and forms, and planning submission workloads. Partner with the Regulatory Associate to retrieve, publish, and submit Modules 1-5 reports/documents and combine files into electronic...


  • Bengaluru, Karnataka, India Lilly Full time

    We're seeking a highly skilled Regulatory Publishing Specialist to join our team at Lilly. As a key member of our Regulatory Publishing team, you will be responsible for managing submissions, planning submission workloads, and partnering with regulatory associates to retrieve, publish, and submit modules 1-5 reports/documents and combine files into...


  • Bengaluru, Karnataka, India Lilly Full time

    Job SummaryWe are seeking a highly skilled Regulatory Publishing Specialist to join our team at Lilly. As a key member of our Regulatory Affairs department, you will be responsible for managing submissions, coordinating global registration activities, and ensuring compliance with regulatory requirements.Key ResponsibilitiesManage submissions, including...


  • Bengaluru, Karnataka, India Elanco Full time

    At Elanco, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets.We pride ourselves on fostering a diverse and inclusive work environment, where diversity is the driving force behind innovation, creativity, and overall business success.This role is responsible for working with multiple...


  • Bengaluru, Karnataka, India ScaleneWorks Full time

    Job SummaryWe are seeking a skilled Transaction Processing Specialist to join our team at ScaleneWorks. In this role, you will be responsible for publishing and assembling submissions within the specified training period.Key Responsibilities:Publishing, assembly, and distribution of submissions within the set timeframe.Notifying relevant stakeholders when...


  • Bengaluru, Karnataka, India ScaleneWorks Full time

    Key Responsibilities:• Successfully meet and complete training milestones relevant to the position held.• Develop and maintain familiarity with FDA, GCPs, ICH guidelines, and the Life Sciences & Pharmaceutical industry.• Perform submission publishing, assembly, and distribution activities within the specified training period.• Notify relevant...


  • Bengaluru, Karnataka, India ScaleneWorks Full time

    **Regulatory Publishing Job Overview**ScaleneWorks is seeking a highly skilled Regulatory Publishing Professional to join our team. This role will be responsible for successfully meeting and completing training milestones relevant to the position held.**Key Responsibilities**Familiarity with FDA, GCPs, ICH guidelines, and the Life Sciences & Pharmaceutical...


  • Bengaluru, Karnataka, India Genpact Full time

    About the RoleWe are seeking a skilled Technical Document Publisher to join our team at Genpact. This role demands an experienced publisher with a proven ability to execute responsibilities in a highly regulated and process-driven environment.ResponsibilitiesPublishing and performing technical validation (eCTD/CTD/NeeS/Paper) for LATAM and Canadian...

  • Publishing Specialist

    3 weeks ago


    Bengaluru, Karnataka, India Lilly Full time

    We're seeking a Publishing Specialist to manage eCTD submissions and maintain regulatory compliance.Main Responsibilities:Prepare submission cover letters and forms for review and approval.Plan submission workload by reviewing the RDE RIM or Share Point Calendar for planned documents.Partner with the Regulatory Associate to retrieve, publish, and submit...


  • Bengaluru, Karnataka, India Genpact Full time

    ✅ Job OverviewGenpact is seeking a highly skilled Regulatory Affairs Specialist to join our team.The ideal candidate will possess a strong background in ECTD submissions, publishing systems, and regulatory guidelines.Key ResponsibilitiesPublishing and validating technical submissions (eCTD/CTD/NeeS/Paper) for the LATAM and Canadian regions.Performing final...


  • Bengaluru, Karnataka, India Genpact Full time

    At Genpact, we are seeking a skilled Regulatory Affairs Specialist to join our team. This role demands an experienced publisher with a demonstrated ability to execute responsibility in a highly regulated and process-driven environment.The ideal candidate will have a deep understanding of eCTD types of submissions and industry-standard publishing systems....


  • Bengaluru, Karnataka, India Biocon Full time

    Job Title: Regulatory Affairs SpecialistJob Summary: We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Biocon. The successful candidate will be responsible for preparing, reviewing, and submitting ANDA/ANDS in the US market, including modules.Key Responsibilities:Hands-on experience in preparation, review, and submission of...


  • Bengaluru, Karnataka, India Epsilon Full time

    About the RoleWe are seeking a skilled Publisher Growth Specialist to join our team at Epsilon. This role will be responsible for supporting the publisher development team in managing and growing publishers working with CJ Affiliate.


  • Bengaluru, Karnataka, India Genpact Full time

    About the RoleGenpact is seeking a skilled Publisher Specialist to join our team. As a Publisher Specialist, you will be responsible for publishing and performing technical validation of eCTD submissions for US submissions.Key ResponsibilitiesPerform final technical quality review of eCTD submissions.Dispatch submissions to the relevant authority...


  • Bengaluru, Karnataka, India Lilly Full time

    We're seeking a highly skilled Regulatory Submission Specialist to join our team at Lilly. As a key member of our Regulatory Department, you will play a critical role in ensuring compliance with regulatory requirements and timely submission of documents to global regulatory agencies.Main Responsibilities:Manage Submissions: Prepare and submit regulatory...


  • Bengaluru, Karnataka, India Genpact Full time

    Transforming Regulatory Submissions with ExpertiseWe're harnessing the power of technology and humanity to create meaningful transformation in the field of pharmaceutical publishing.About the RoleWe're seeking a highly skilled Associate Publisher - eCTD Submissions to join our team at Genpact. As a key member of our publishing team, you will be responsible...


  • Bengaluru, Karnataka, India Elanco Full time

    At Elanco, we're driven by our vision of 'Food and Companionship Enriching Life' and our approach to sustainability – the Elanco Healthy Purpose – to advance the health of animals, people, the planet and our enterprise.As a global leader in animal health, we're dedicated to innovation and delivering products and services to prevent and treat disease in...