Regulatory Associate I
1 DNA Way South San Francisco, CA 94080
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.
- Responsible for product labeling, including the carton, label and insert labeling components.
- Initiate labeling changes via the artwork process
- Review and proofread the labeling changes
- Track labeling changes and project manage through the artwork process
- Approve labeling changes
- Close out labeling files, ie electronic file closeout
- Process and submit labeling portion of the Biologics License Application (BLA) and New Drug Applications (NDA) yearly Annual Reports.
- Utilize database and RAPID system to compile data.
- Partner with Regulatory Submissions group to submit labeling portion of Annual Reports
- Special projects as assigned.
- Exceptional proofreading skills and attention to detail
- Effective time management
- Able to work independently
- Ability to learn and adapt to new systems and processes
- Abililty to work within tight timelines and prioritize workload
- Fluent in Word, Powerpoint, Excel
- Familiar with Adobe Acrobat
- Familar with Touchpoint, RAPID, Trackwise
- 5 years Pharm/Biotech experience
- Regulatory experience desired
- Bachelors Degree required (Life Sciences disciplines strongly preferred)
- Quality experience is a plus