Regulatory Submissions Specialist – US

Celegence is looking for a Regulatory Submissions Specialist located in or near Chicago, IL to support a major client with ongoing submissions.

Roles & Responsibilities

  • Serve as a member of delivery team responsible for lifecycle management related to regulatory publishing and submission for medicinal products
  • Compile the dossier in the required format of submission to the relevant agencies
  • Assist with the submission of IND’s, NDA’s, BLA’s, ANDA, and Annual Reports for US, Canada
  • Prepare forms FDA 1571, 3674, 356h, cover letters along with regulatory documents for submission to FDA
  • Track, process, publish, and archive 1572 submission to FDA
  • Create and submit the 15-day and 7-day safety reports to FDA
  • Process and publish Chemistry Manufacturing and Controls (CMC) and related documents, clinical study reports, preclinical reports, annual reports, aggregate reports, original IND/NDA dossiers ensuring final documents meet company specifications and FDA guidelines for electronic navigation
  • Generate Microsoft Word Table of Contents (ToC) and PDF ToC using ISI Publisher tool
  • Create hyperlinks and bookmarks using ISI Publisher tool
  • Handle files of different file formats such as PDF, MS-Word, XML, JPEG, SAS Datasets and program files
  • Use advanced features in ISI Toolbox like Splitting of documents, Merging, Batch process, Optimizing PDFs and Bookmark and Link Auditor
  • Import and archive of documents in DocuBridge, SharePoint and Documentum – tools used for document management
  • Provide eQC review of CMC and related documents, clinical study reports, preclinical reports, annual reports, aggregate reports, original IND/NDA dossiers ensuring final documents meet company specifications and FDA guidelines for electronic navigation
  • Transmit different application submission to FDA through Electronic Submission Gateway (ESG)
  • Provide regulatory technical assistance by supporting proper implementation of regulatory activities within specified timeframes
  • Identify document processing and eQC areas for improvement and resolve issues as necessary
  • Maintain metrics of all submissions to FDA and ensure all submissions are archived along with FDA acknowledgements in document management system according to company standards
  • Assess regulatory pathways for new product platforms and product modifications; develop and implement regulatory strategies and tactical plans for submissions to US FDA and international regulatory agencies, as needed
  • Collaborate to develop workarounds for tools and process issues. Identify and troubleshoot any technical issues related to document processing, submission publishing and tools required for document and submission eQC
  • Collaborate with cross-functional project teams to coordinate and implement submission strategies and positioned to meet strategic corporate goals
  • Ensure targets and compliance reporting requirements are achieved in accordance with established timelines for key deliverables
  • Adhere to appropriate regulatory guidelines, departmental SOPs and Client SOPs for the deliverables
  • Complete trainings provided by Client, and regular self-trainings; archive training certificates/records
  • Assist and support internal audits performed by Client

Education & Experience

Education:

  • Bachelor’s Degree in Life Sciences or Information Technology. Master’s Degree is preferred
  • RAC certification is a plus

Experience:

  • Minimal 3 years working experience in regulatory operations and regulatory affairs
  • Experience as a publisher for regulatory applications including submission activities
  • Fluent in English

Skills and Competencies

Technical / Functional Skills:

  • Experience with eCTD technologies, Microsoft Office, Adobe Acrobat. Document management system
  • Basic understanding of IT infrastructure
  • Understanding of the drug development process. Knowledge of generics and branded product development a plus
  • Working knowledge of industry legislation and best practices
  • Knowledge of regulations/guidelines governing regulatory submissions

Non-Technical Skills:

  • Possess strong verbal and written communications skills, strategic thinking, ability to influence others & problem resolving skills
  • Good knowledge of submission processes including QC activities
  • Possess strong verbal and written communications skills, strategic thinking, ability to influence others & problem resolving skills

Competencies:

  • Excellent Communication (Writing and Verbal)
  • Customer Focused
  • Organization Skills
  • Strong Time management
  • Good Stakeholder management
  • Project management and tracking

Personal Traits:

  • Positive Attitude
  • Initiative and Commitment
  • Leadership Skill
  • Detailed Oriented
  • Team player
  • Focused and sincere
  • Perseverance

Please make sure you have the relevant work visa prior to applying

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