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EW
Eastridge Workforce Solutions
US Regulatory Lead
Career Insights for Regulatory Affairs Specialist
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What they do
A Regulatory Affairs Specialist maintains specialized knowledge of state and federal government regulations that affect an employer. Interprets regulations and implements procedures that bring an employer into compliance with regulations; may audit internal compliance with regulations.
$111,513 / year median in the U.S.
+5% projected growth
Job Description
US Regulatory Lead Eastridge Workforce Solutions - 3.9 Boston, MA Job Details Temporary | Full-time | Contract $101 - $115 an hour 20 hours ago Qualifications FDA submissions Research Investigational new drug (IND) applications Bachelor's degree Regulatory submission editing and review Communication with regulatory authorities for clinical trials Full Job Description 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.
Created/Revised Date:
August 25, 2026Anticipated Closing Date:
September 21, 2026Job Title:
US Regulatory Lead Location:
Remote - US; strong preference for candidates inEST Shift:
Monday-Friday, 40 hours per week; business hours aligned with East Coast timeHourly Pay Range and Other Compensation:
- The hourly rate for this position is expected to be between $101.
Employment Type:
Temporary - 6-month contract with potential for extensionFLSA Status:
Non-Exempt Schedule:
Monday-Friday, 40 hours per weekJob 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 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.
- Little to no travel is expected.
- Ability to work East Coast business hours; candidates located in EST are strongly preferred.