Senior Regulatory Affairs Program Manager

Position Summary

The Senior Regulatory Affairs Program Manager leads complex cross‑functional regulatory initiatives from strategy through execution, ensuring products meet global regulatory requirements and are delivered in alignment with business objectives and launch timelines. Partners with R&D, Clinical, CMC, Manufacturing, and Commercial; serves as a key regulatory liaison.

• Lead design, planning, and execution of complex cross‑functional regulatory programs (plans, timelines, milestones, deliverables, resources, risk mitigation).
• Drive cross‑functional collaboration (Regulatory Affairs, Quality, Clinical, R&D, Operations, Manufacturing, Commercial).
• Provide program leadership/governance: milestone tracking, dependency management, escalation, and executive/external status updates.
• Author/revise/maintain SOPs, work instructions, regulatory processes, and templates.
• Mentor junior team members and cross‑functional partners.
• Support regulatory inspections, audits, and health authority interactions (responses, documentation, commitments/corrective actions).
• Lead/contribute to special projects and business‑critical cross‑functional initiatives.

• Bachelor’s degree in sciences/business/project management or related field + 8+ years relevant progressive experience (required).
• 5+ years leadership (preferred).
• 6+ years regulatory affairs in pharma/biologics/medical device (preferred).
• 5+ years managing complex, multi‑regional regulatory programs (preferred).

• FDA and other global health authority requirements; regulatory submissions/compliance experience (preferred).
• Strong collaboration, multitasking, communication, analytical/problem‑solving, and risk mitigation.
• Microsoft Office + project tools (e.g., ); document/regulatory systems a plus.
• Independent, accurate, fast‑paced.
• Continuous improvement and compliance focus.

• Discretionary bonus and equity;
  Medical, Dental, Vision; wellness programs; EAP; life/AD&D; short/long‑term disability; FSAs; 401(k) match; 529; PTO (11 holidays) / Unlimited PTO for exempt; vacation/personal/cultural days for non‑exempt.