New Jersey, USA
4 days ago
Looking for a new position with an innovative biotech in New Jersey? This trailblazing company is working on research and development of products across multiple therapeutic areas with a focus in new drug delivery technologies. Working with this collaborative team will add significant regulatory experiences to your already impressive background!
- Ability to publish submissions electronically using eCTD software application to industry and company standards
- Offer IND and NDA submission lifecycle maintenance support
- Can independently format submission source documents with use of company approved templates and send for review in EDMS
- Maintain and support regulatory systems as required
- Produce regulatory publishing and submission processes and SOPs as needed
- Work cross-functionally in reviewing docs from publishing standpoint as well as prepare for submission readiness
- 5+ years of pharma experience/3-5 years of regulatory operations/submissions experience
- MS word formatting and adobe experience preferred (Toolbox knowledge a plus)
- Quick on feet, can work collaboratively in a team environment
- Impeccable organizational skills and comfortable with embracing change
- Excellent communication skills and can work in a fast-paced environment
If this amazing opportunity sounds like a role for you, please contact me directly at email@example.com or 347-493-0273.