Regulatory Submission Coordinator (m/f)

Job type:
on-site
Start:
asap
Duration:
6 MM++
From:
Hays AG
Place:
in Basel region
Date:
07/16/2012
Country:
flag_no United Kingdom

Project description:
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We are looking for a
Regulatory Submission Coordinator (m/f)

Referenz: en
Beginn: asap
Dauer: 6 MM++
Ort: in Basel region
Branche: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen

Ihre Aufgaben:
  • Support and provide coordination, compilation and publishing expertise in the preparation of new and existing regulatory applications including initial applications (CTAs, INDs, MAAs, NDAs etc.), amendments, supplements, variations and other submissions in compliance with health authority regulations
  • Primary focus is on regulatory submissions of low to moderate complexity both eCTD and non-eCTD format, including single Module accountability for large submissions
  • Providing regulatory and technical input and contributing in project planning
  • Lead and coordinate the compilation of paper submissions and assembly of electronic submissions in eCTD
  • Perform publishing activities using various electronic technologies including electronic publishing
  • (e.g. gCTD, InSight Publisher & Core Dossier) and electronic document management (Documentum)
  • Liaise with regulatory product managers, concerned functions and external business partners organizations when applicable; facilitate communication and collaboration to meet submission timelines and plan future work
  • Perform occasional report publishing in collaboration with authors across functions
  • Coordinate EU Annexes translations with product managers, EU affiliates and other functions and ensure adherence to EMEA/QRD requirements: provide support in the preparation of the English Annexes, initiate & coordinate translation activities
  • Assist in assuring adherence to current publishing processes and standards and support development of new publishing standards and processes
  • Contribute to the improvement of submission processes and working practices through working groups, submission debrief meetings
  • Write / update submission guidelines and SOPs, as well as conduct user training


Ihre Qualifikation
  • Excellent oral and written English communication skills
  • Extensive experience in MS Word, Excel, eCTD requirements, lifecycle management, Adobe Acrobat & ISI Toolbox and Compose
  • Working knowledge of ICH, FDA, EU dossier structural requirements
  • Commitment to quality
  • Planning and organization ability
  • Analytical skills & problem solving ability
  • Customer focus



Skills:
- Regulatory affairs assistant


Keywords: Assistant regulatory affairs freelance contractor freelancer contract contr contracting self-employed project Projekt