Associate Director, Project Manager - Regulatory Affairs

Scorpion Therapeutics; United States; On-site; USD 150,000 - 195,000; Full time

Job summary

Scorpion Therapeutics is seeking an Associate Director, Regulatory Project Manager to lead and coordinate global regulatory affairs activities for rare disease therapies. You will create regulatory timelines, align cross-functional teams, and oversee major submissions (INDs, NDAs, BLAs) and routine maintenance.

You will partner with Regulatory Leads, drive risk mitigation, manage dashboards and status reports, and mentor junior staff. Travel <10% and onsite work in San Diego are expected as part of face-to-face collaboration.

Qualifications

• 8+ years project management in biotech/pharma; regulatory-specific PM preferred.
• PMP certification strongly preferred.
• Experience with timeline development/management software such as Smartsheets and MS Project.

Responsibilities

• Lead regulatory project management for one or more global development programs; align plans, timelines, deliverables, and submissions with strategy and priorities.
• Partner with Regulatory Leads to run Global Regulatory Team meetings (agenda, decisions, documentation, follow-up).
• Develop and maintain integrated regulatory project timelines with health authority milestones, dependencies, deliverables, and key decisions.
• Plan and track major regulatory submissions/maintenance (INDs, NDAs, BLAs, supplements, annual reports, DSURs, post-marketing commitments, responses).
• Coordinate cross-functional execution with Regulatory Ops/Affairs, Clinical Development/Ops, CMC, Biostatistics, Medical Writing, Quality, Commercial, and external partners/vendors.
• Support submission planning/readiness (content planning, timelines, document ownership, review cycles, Vault RIM activities).

Skills

Regulatory PM experience

Global cross-functional coordination

Stakeholder communication

Risk management

Team leadership

Education

Bachelor’s in Life Sciences

MS/PharmD/PhD preferred

Tools

Smartsheets

MS Project

Job description

Position Summary:

The Associate Director, Regulatory Project Manager (RPM) leads and coordinates global regulatory affairs activities to ensure compliance with health authority requirements for investigational and commercial rare disease therapies. Creates regulatory project timelines/dashboards, schedules cross-functional meetings, and tracks regulatory commitments.

Responsibilities:

• Lead regulatory project management for one or more global development programs; align plans, timelines, deliverables, and submissions with strategy and priorities.
• Partner with Regulatory Leads to run Global Regulatory Team meetings (agenda, decisions, documentation, follow-up).
• Develop and maintain integrated regulatory project timelines with health authority milestones, dependencies, deliverables, and key decisions.
• Plan and track major regulatory submissions/maintenance (INDs, NDAs, BLAs, supplements, annual reports, DSURs, post-marketing commitments, responses).
• Coordinate cross-functional execution with Regulatory Ops/Affairs, Clinical Development/Ops, CMC, Biostatistics, Medical Writing, Quality, Commercial, and external partners/vendors.
• Support submission planning/readiness (content planning, timelines, document ownership, review cycles, Vault RIM activities).
• Create/maintain dashboards, milestone trackers, and status reports; report progress, risks, issues, and upcoming deliverables.
• Identify/mitigate risks, constraints, resource gaps, and dependencies.
• Coordinate health authority interactions, advisory committee activities, inspection readiness, audits, and regulatory responses.
• Drive continuous improvement of PM processes/tools/templates.
• Manage regulatory project documentation in designated systems.
• Provide leadership/mentoring; may manage direct reports and support resource planning.

Education/Experience:

• Bachelor’s in Life Sciences (MS/PharmD/PhD preferred). 8+ years project management in biotech/pharma; regulatory-specific PM preferred.
• PMP certification strongly preferred.
• Timeline development/management software expertise (e.g., Smartsheets, MS Project).

Additional Skills:

• Strong global regulatory affairs/compliance knowledge for rare disease therapies.
• Excellent organization, multitasking, scheduling, risk management, and stakeholder coordination.
• Strong communication and problem-solving; experience managing complex project plans/timelines/critical paths.
• Adaptable to plan changes; travel <10%.
• Not 100% remote; face-to-face/onsite work in San Diego required.

Benefits:

• Premium health, financial, work-life/well-being; wellness/support programs; life insurance, disability; retirement with employer match; generous paid time off.

Compensation:

• - Target base pay range: $150,000–$195,000.