Regulatory Writing Sr Mgr (Biotech)

Location: Washington, D.C., United States

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 applications and biologics license applications.
• Author or oversee regulatory submission documents, including clinical study reports, investigator brochures, protocols, informed consent forms, briefing documents, and pediatric investigation plans.
• Review and approve regulatory documents in accordance with applicable standard operating procedures.
• Serve as the regulatory writing lead on global regulatory, evidence generation, safety, and labeling teams.
• Supervise contract and freelance writers, mentor junior medical writers, and lead departmental initiatives.
• Develop document timelines and provide input into global regulatory plans and team goals.

Requirements

• Doctorate degree and 2 years of directly related experience; or master's degree and 6 years; bachelor's degree and 8 years; associate's degree and 10 years; or high school diploma/GED and 12 years.
• At least 5 years of medical writing experience in the biotechnology or pharmaceutical industry.
• Experience preparing regulatory documents in Regulatory Affairs, Research and Development, or a related area.
• Experience leading complex submissions and collaborating with cross-functional product teams.

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, plus career development opportunities.