Regulatory Writing Senior Manager (Biotech)

Location: United States — Remote

Salary: $139,581.90–$188,846.10 per year

Company

hirify.global is a biotechnology company researching, manufacturing, and delivering medicines to patients worldwide.

What you will do

• Lead regulatory writing activities for complex drug and biologics submissions.
• Author or oversee clinical and regulatory documents, including Clinical Study Reports, Investigator Brochures, protocols, informed consent forms, briefing documents, and Pediatric Investigation Plans.
• Conduct formal document reviews and approvals in accordance with applicable standard operating procedures.
• Serve as the regulatory writing lead on cross-functional product teams and contribute to global regulatory plans and team goals.
• Supervise contract and freelance writers, mentor junior medical writers, and lead departmental initiatives.
• Generate document timelines for submission activities.

Requirements

• Doctorate degree and 2 years of directly related experience, or a Master’s degree and 6 years, or a Bachelor’s degree and 8 years, or an Associate’s degree and 10 years, or a high school diploma/GED and 12 years.
• Experience with regulatory documents in Regulatory Affairs, Research, Development, or a related area.
• 5+ years of medical writing experience in the biotechnology or pharmaceutical industry preferred.
• Must be based in the United States for this remote role.

Culture & Benefits

• Comprehensive health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Discretionary annual bonus program and stock-based long-term incentives.
• Paid time-off plans and biannual company-wide shutdowns.
• Flexible work models, including remote arrangements where possible.
• Career development opportunities and support for work-life balance.