Regulatory Publishing Specialist

1 month ago


Bengaluru, Karnataka, India Lilly Full time
Job Summary

We 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 Responsibilities
  • Manage submissions, including preparing submission cover letters and forms, and coordinating with regulatory agencies.
  • Coordinate global registration activities, including preparing and submitting regulatory documents, and ensuring compliance with regulatory requirements.
  • Partner with the Regulatory Associate to retrieve, publish, and submit Modules 1-5 reports/documents and combine files into electronic submissions (eCTD) according to the master table of contents or Content Plan for the dossier.
  • Share knowledge, help train and educate others on general submission knowledge, including CRFs, datasets, submission required literature references, periodic reports, post-Marketing supplements, and amendments.
  • Coordinate global registration activities and provide the necessary documentation to affiliates for registration of products in global countries.
  • Submit and archive submitted registrations, incoming correspondence, and Records of Contact with Regulators, assuring all metadata fields are complete in eFiles or RIM.
  • Manage FDA Web trader account to enable submissions via electronic gateway.
  • Achieve a high level of technical and practical proficiency with eCTD XPress, Adobe Acrobat, Submission Validation software (Lorenz), ISIToolbox.
  • Stay up to date on system and tool upgrades that impact publishing.
  • Share technical information among staff members and apply what is learned in day-to-day work.
  • Apply learning from quality review of submission work.
  • Keep up to date in subject matter expert area.
Requirements
  • High school diploma or equivalent required; Bachelor's degree in a related field preferred.
  • Minimum 2 years of experience in regulatory publishing or a related field.
  • Excellent communication and interpersonal skills.
  • Ability to work in a fast-paced environment and prioritize multiple tasks.
  • Strong analytical and problem-solving skills.
  • Proficiency in eCTD XPress, Adobe Acrobat, Submission Validation software (Lorenz), ISIToolbox.
What We Offer

Lilly is an equal opportunity employer and welcomes applications from diverse candidates. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.

#WeAreLilly



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