Regulatory Writing Senior Manager

For our client, we are seeking a Regulatory Writing Senior Manager to join the team of a leader in the Pharmaceuticals & Biotech space. This role will guide regulatory writing strategy and execution for complex development programs, supporting high-quality submissions across a fast-moving, highly regulated environment. The position partners closely with cross-functional product teams and regulatory stakeholders to ensure documents are accurate, compliant, and aligned with broader program goals. In addition, this leader will mentor writers, manage outsourced support, and help drive departmental initiatives that strengthen consistency and efficiency across the organization. Location: Remote - US based candidates only, no visa sponsorship available Compensation: $139,582 – $188,846 annually Responsibilities Author or oversee regulatory submission documents, including Clinical Study Reports and Investigator Brochures Conduct formal reviews and approvals of authored documents in accordance with standard operating procedures Lead regulatory writing activities for complex product submissions with limited supervision Serve as the functional area lead on product teams such as Global Regulatory Team and Evidence Generation Team Provide functional area input for the Global Regulatory Plan and team goals Supervise contract and freelance writers and mentor junior medical writers Lead departmental and cross-departmental initiatives as needed Qualifications Doctorate degree with 2 years of related experience, or a Master's degree with 6 years, or a Bachelor's degree with 8 years, or an Associate's degree with 10 years, or a high school diploma/GED with 12 years of related experience Experience with regulatory documents in Regulatory Affairs, Research, Development, or a related area 5+ years of experience in medical writing in the biotech/pharmaceutical industry Benefits Comprehensive medical, dental, and vision coverage Retirement and savings plan with generous company contributions Discretionary annual bonus program or sales-based incentive plan for field sales representatives Stock-based long-term incentives Award-winning time-off plans and bi-annual company-wide shutdowns Flexible work models, including remote work arrangements Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.