Regulatory Writing Sr Mgr

This role will provide business-aligned guidance focused on governance, compliance, and operational risk management. You will partner with leaders, compliance stakeholders, and cross-functional teams to translate complex issues into practical recommendations, strengthening responsible execution, improving decision-making, and supporting sustainable growth within a life sciences environment.

Location: Remote - US based candidates only, no visa sponsorship available

Responsibilities

• Author or oversee various regulatory submission documents including Clinical Study Reports and Investigator Brochures
• Review and approve authored documents per standard operating procedures
• Lead regulatory writing for complex submissions like new drug applications with limited supervision
• Serve as the functional area lead on cross-functional product teams
• Provide input for the Global Regulatory Plan and team objectives
• Supervise contract and freelance writers, mentoring junior medical writers
• Lead departmental and cross-departmental initiatives and generate document timelines

Qualifications

• Doctorate with 2 years of related experience, or Master’s with 6 years, or Bachelor’s with 8 years, or Associate’s with 10 years, or High school diploma/GED with 12 years of related experience
• 5+ years of experience in medical writing within the Biotech/Pharmaceutical industry is preferred
• Experience with regulatory documents in Regulatory Affairs, Research, or Development

Pay

$139,582 – $188,846 annually

Benefits

• Comprehensive benefits package with health, dental, and vision coverage
• Discretionary annual bonus program and stock-based long-term incentives
• Generous retirement and savings plan contributions by the company
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote options when possible