Regulatory Information Specialist
One DNA Way South San Francisco, California 94080 | Contract
Our client is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. They are among the world' s leading biotech companies, with multiple products on the market and a promising development pipeline.
- Ensure technical documentation support by preparation and formatting of regulatory documents; maintenance of regulatory documents in the document management system; compilation of submission dossiers, hand-over to publishing.
- Participate in SMG and PTR initiatives by providing input on future system enhancements and business process updates.
- Prepare and update technical regulatory documents according to instructions from the PTR product manager or the submission manager and ensure adherence to applicable regulatory (e.g., CTD) and Roche CMC documentation standards.
- Format detailed data tables and figures and apply document formats using customized Word templates.
- Compile regulatory dossiers and format them for publishing.
- Hand over the dossier for publishing to the respective publisher.
- Maintain regulatory documents in document-management systems (e.g., Documentum) and document-sharing systems (e.g., SharePoint).
- Collaborate with PTR product managers and with internal partners.
- Actively participate in SMG and PTR initiatives.
- Minimum BA or BS (or equivalent) in English, biology, chemistry, pharmacy, or a related field or a degree as laboratory assistant (e.g., CTA, BTA, or PTA) or Kaufmännische Ausbildung; or three to five years of experience in a similar role.
- Previous experience with regulatory documents and dossier structures (e.g., CTD ) or in the biotech or pharmaceutical industry is beneficial.
- Proficiency in a broad range of IT skills, including expert-level use of Word, Excel, and Acrobat and experience with document-management systems (e.g., Documentum) and document-sharing systems (e.g., SharePoint). Knowledge of publishing systems and requirements is beneficial.
- Tenacious attention to detail and consistency, especially with respect to style, format, and layout and ability to format technical documents using electronic tools (e.g., Acrobat).
- An aptitude for teamwork and the ability to interface effectively with PTR submission leads and colleagues located in other countries.
- Strong organizational and time-management skills; the ability to deliver under pressure; and the ability to work flexibly to support changing assignments and priorities in an independent and reliable manner.