US Regulatory Lead

We are seeking a US Regulatory Lead to work in a 6 month role (could be extended, but not guaranteed),
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.

Pay Range: $101.00/hr -$115.00/hr.

Primary Responsibilities

• Collaborates with and assists other US Regulatory Leads with project deliverables, preparing for FDA meetings, conducting regulatory research, regulatory intelligence, and/or preparing slides on regulatory topics
• May serve as US Regulatory Lead for new products or new indication expansions for marketed products
• Represents US Regulatory function in various cross functional teams (for example, clinical study teams, oncology-specific workgroups, global regulatory team for newly assigned programs, etc.)
• Responsible for IND/NDA/BLA submissions and collaborates with assigned resource for maintenance activities
• Coordinates mapping and authoring of end-to-end process descriptions for specific types of regulatory submissions
• May assist 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

Travel and Location

• Little to no travel is expected
• This role is 100% remote

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, Los Angeles County Fair Chance Ordinance, and San Francisco Fair Chance Ordinance.