12 days ago on roche.com

Submission Support Manager in Roche Pharma Technical Regulatory

Roche AG

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Submission Support Manager in Roche Pharma Technical Regulatory

Submission Support Manager in Roche Pharma Technical Regulatory

Switzerland, Basel-Town, Basel

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  • Job facts

In this role you will support Pharma Technical Regulatory (PTR) product managers by managing the flow of regulatory documents through the submission preparation and review processes, as well as editing and formatting draft documents. You will also participate in Submission Management Group (SMG) and PTR initiatives by providing input on future system enhancements, business process updates, and submission model documents.

Primary duties and responsibilities will be:

  • Edit complex, often lengthy technical documents for clarity, grammar, spelling, and punctuation; for adherence to applicable regulatory (e.g., CTD) and Roche guidelines; and for consistency within the dossier
  • Apply document styles using customized Word templates and coordinate the flow of documents via document-sharing systems (e.g., SharePoint) and ensure version control throughout the submission generation process (writing, review, and internal approval)
  • Support PTR product managers in generating submission timelines; plan and track submission generation activities (e.g. Excel) and evaluate submission-support strategies, as appropriate
  • Communicate with technical subject-matter experts to ensure that content is delivered according to schedule and to provide status updates; coordinate and provide training on documentation systems and tools and collect relevant submission related data
  • Facilitate submission reviews and review adjudication meetings and perform live editing to capture stakeholders’ decisions
  • Represent SMG in Technical Regulatory Teams and in Technical Development Teams, as well as in cross-functional meetings, projects and initiatives, as needed

  • Who you are
    You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

    Besides being an excellent teamworker and politically adept, your qualifications and experience are as follows:

    • Minimum BA or BS (or equivalent) in English, biology, chemistry, pharmacy, or a related field plus a strong track record as an editor, including at least three years of professional editing experience, preferably in a scientific or technical field.  Previous experience with regulatory documents (e.g., in CTD structure and other ICH, FDA, and EMA guidelines) and global submission dossiers or in the biotech or pharmaceutical industry is beneficial
    • Tenacious attention to detail and consistency, especially with respect to grammar, usage, spelling, punctuation, and style; familiarity with standard style guides
    • Ability to communicate clearly and professionally, both orally and in writing, both in English and in German
    • Expert-level use of Word, Excel, PowerPoint, and Adobe Acrobat and experience with document management systems (e.g., Documentum) and document sharing systems (e.g., SharePoint)


  • Who we are
    Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 8,500 people from approximately 90 countries work in Basel, which is one of Roche`s largest sites. Read more.

    Roche is an equal opportunity employer.
  • Job facts
    • Location Switzerland, Basel-Town, Basel
    • Function Regulatory Affairs
    • Subfunction Technical Regulatory Affairs
    • Schedule Full-time
    • Job level Individual Contributor
    • Job type Regular Employee
    • Division Roche Pharmaceuticals
    • Date 2016/10/11
    • Job-ID 2756796747
  • Get in touch
    Manuel Zumkeller-El Manchi+41 61 688 90 43
    Work location: Basel
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