US Regulatory Lead
Ledgent Technology · Boston, MA · 1 mo ago
RemoteRemoteOTHR$101–$115/hrContract
Primary Responsibilities
- Collaborates with and assists other US Regulatory Leads with project deliverables
- Prepares for FDA meetings
- Conducts regulatory research
- Regulatory intelligence
- Prepares slides on regulatory topics
- Serves as US Regulatory Lead for new products or new indication expansions for marketed products
- Represents US Regulatory function in various cross-functional teams
- Coordinates mapping and authoring of end-to-end process descriptions for specific types of regulatory submissions
- Assists with US regulatory assessment of external innovation opportunities
Education and Required Skills
- BS/BA in relevant scientific discipline, advanced degree is a plus
- Knowledge and experience of US FDA regulatory requirements and submissions, including filing of IND/NDA/BLA to FDA
- 7-10 years Regulatory Affairs experience, more experience preferred
Desired Skills and Experience
- US regulatory affairs
Pay and Benefits
Pay Range: $101.00/hr - $115.00/hr
Duration: 6 months; potential for extension only at this time (and not guaranteed)
The role is W2 hourly with Roth Staffing (Ultimate Staffing and Ledgent Technology is a division of Roth Staffing)
No 3rd party candidates can be considered for this role
This role is 100% remote