Regulatory Publishing Specialist
1 month ago
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.
- 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.
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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