CMC Regulatory Writer / Coordinator – CMC Program Management

Main focus: CMC Writer
Date posted: 17. May 2022
Location: Vienna

Position Summary

As a CMC Regulatory Writer / Coordinator you are responsible for managing the preparation of documents for regulatory submissions. You compile information for CMC sections of regulatory submissions out of source documentation and author those sections. You are a clear and precise writer with a detail-oriented, motivated, and independent way of working. You have experience in project management and take responsibility in your field of expertise. A strong background in biotechnology and excellent writing skills, as well as an ability to work in a fast-paced environment in a cross-functional team are essential behaviors for this role.

Main Responsibilities
  • Coordinate the preparation of documents for regulatory submissions to meet agreed-upon timelines
  • Provide guidance on necessary source documentation and level of detail to subject matter experts 
  • Analyze and extract relevant information out of source documents
  • Write / Prepare submission-ready documents for submission to regulatory authorities in the U.S. and in Europe
  • Review, edit, and finalize documents in collaboration with subject matter experts and CMC Regulatory experts

Qualifications

  • More than two years of experience in preparation of submission-ready documents for CMC sections regulatory submissions (IND, IMPD) for viral vector products or cell and gene therapies
  • Strong knowledge of the regulatory requirements for CMC sections for IND and IMPD submissions
  • Experience with technical regulatory writing
  • Experience in communication with Regulatory Authorities
  • Strong background in Biotechnology or a related field (University Degree) or comparable
  • Self-motivated with a great sense of ownership in the area of responsibility
  • Great time-management, ability to perform very well under time pressure
  • Ability to work with a cross-functional team
  • Fluent in English, both spoken and written
  • Valid EU working permit

What we offer

  • Strong team with dedicated and passionate employees
  • State of the art infrastructure
  • An excellent working atmosphere
  • Opportunities for personal development
  • Employee benefits such as health screening, public transportation card, Sodexo pass
  • Working in a multinational and multicultural environment

We are required by Austrian law to post a minimum salary. The minimum monthly gross salary for this position is EUR 3.643,- based on fulltime (40 hours per week); depending on experience and qualification salary can be negotiated. In addition, we offer a performance-related bonus payment and participation in our stock option compensation program.

Starting date: as soon as possible

Contact:

If you (m/f/d) are interested in this challenging position, please send your CV including a cover letter (summarizing your qualification and experiences) as well as your credentials to: talent@hookipapharma.com

For more information on HOOKIPA please visit www.hookipapharma.com

 

Apply Now!