US Regulatory Lead

About the role

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. Location: Remote – US; strong preference for candidates in EST. Employment Type: Temporary – 6‑month contract with potential for extension.

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 workgroups, 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.
• Ability to work East Coast business hours; candidates located in EST are strongly preferred.
• Little to no travel is expected.

Pay

The hourly rate for this position is expected to be between $101.00 and $115.00 per hour, depending on geographic location, experience, and other qualifications of the successful candidate.

Schedule

Monday–Friday, 40 hours per week; business hours aligned with East Coast time.

Benefits

Eastridge Workforce Solutions offers the following benefits, subject to applicable eligibility requirements. Learn more about benefits available to Eastridge’s temporary employees. Due to the varying length(s) of temporary assignments, Eastridge Workforce Solutions’ Temporary Staff are not eligible for paid time off, unless required by applicable state law in which the position is based. However, from time to time Eastridge’s clients may offer additional benefits to Eastridge employees while on assignment. Information about those benefits will be communicated when applicable.