Regulatory Documentation Specialist
As a Regulatory Documentation Specialist you will provide/execute/be responsible to support and provide coordination, compilation and publishing expertise in the preparation of the non-clinical section of regulatory applications (Module 4) including initial applications (INDs, NDAs, etc.) and other submissions in compliance with health authority regulations.
- Coordinate the compilation of the non-clinical documentation for electronic submissions including tracking progress of document delivery, gathering metrics for submission processing, quality assurance, releasing and archiving in accordance with SOPs and guidance documents;
- Ensure high overall submission quality. Provide quality check of Module 4 for final submission;
- Liaise with concerned functions, regulatory product managers and external third-party organizations when applicable;
- Facilitate communication and collaboration to meet submission timelines and plan future work;
- Ensure documents are compliant with company standards and FDA/ICH guidelines. Bookmark and hyperlink PDF documents to ensure adherence to guidelines for incorporation into eCTD submissions using PDF editing tools including Adobe Acrobat® Professional and ISI Toolbox;
- Support non-clinical scientists and external authors in preparing experimental reports and documents for archiving or in support of regulatory submissions. Assist in the use of formatting tools (i.e. Microsoft Word and Adobe Acrobat®);
- Upload eCTD compliant documents into the document management system (RAPID) ensuring proper location and correct metadata entry for regulatory submissions. Submit final reports to the Research Document Repository (RDR) and update the non-clinical study tracking system (SafetyPlan);
- Advise non-clinical scientists on report publishing requirements and processes;
- Support process improvement, participate in working groups, write/update relevant guidance.
Qualifications and Experience:
- Excellent attention to detail and ability to stay focused on detail with large projects;
- Ability to work under time pressure and adapt to quickly changing priorities;
- Advanced technical skills with Microsoft Word;
- Advanced technical skills with Adobe Acrobat; experience with PitStop Pro and ISIToolbox plug-ins a plus;
- Minimum 1 year in a regulatory documentation environment in the pharma industry, preferably in non-clinical regulatory documentation;
- Fluency in English;
- Relevant working/residency permit or Swiss/EU-Citizenship required.