US Regulatory Lead
Listed on 2026-09-18
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Pharmaceutical
Regulatory Compliance Specialist, Healthcare Compliance
US Regulatory Lead
Eastridge Workforce Solutions is committed to connecting skilled professionals with meaningful career opportunities. We are seeking a US Regulatory Lead to support our client's team.
Job Title:
US Regulatory Lead
Location:
Remote – US; strong preference for candidates in EST Shift: Monday–Friday, 40 hours per week; business hours aligned with East Coast time Hourly Pay Range and Other Compensation:
The hourly rate for this position is expected to be between $101.00–$115.00 per hour, depending on geographic location, experience, and other qualifications of the successful candidate.
Employment Type:
Temporary – 6-month contract with potential for extension FLSA Status:
Non-Exempt
Schedule:
Monday–Friday, 40 hours per week
Job Summary:
Eastridge Workforce Solutions is hiring a US Regulatory Lead for a fully remote 6-month contract opportunity with a pharmaceutical organization. This position will support US regulatory activities, FDA submissions, and cross-functional regulatory initiatives. There is potential for an additional 6-month extension based on business needs and performance; extension is not guaranteed.
Essential Duties and Responsibilities:
Collaborate with and assist 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. Represent US Regulatory function in various cross functional teams, including clinical study teams, oncology-specific work groups, and global regulatory teams.
Responsible for IND/NDA/BLA submissions and collaborate with assigned resource for maintenance activities. Coordinate 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.
Requirements: 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. Little to no travel is expected. Ability to work East Coast business hours; candidates located in EST are strongly preferred.
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