Senior Project Manager, Regulatory CMC

Location: San Carlos, California, United States; hybrid work arrangement with 3 days per week onsite.

Salary: $166,000–$195,000 per year in the San Francisco Bay Area; ranges may vary for non-California locations.

Company

hirify.global is a growing biotechnology company developing products that require pharmaceutical and regulatory CMC submissions.

What you will do

• Plan, coordinate, and execute regulatory CMC submissions, including BLAs, Prior Approval Supplements, and other filings.
• Build and manage integrated submission timelines, authoring and review cycles, publishing schedules, and health authority response activities.
• Coordinate Regulatory and CMC subject matter experts, external manufacturing partners, and cross-functional project teams.
• Lead meetings, maintain documentation, track action items, and communicate project status, risks, and dependencies to stakeholders and leadership.
• Manage Statements of Work with external CMOs and track deliverables through completion.
• Develop trackers, dashboards, processes, and tools to improve regulatory CMC project management workflows.

Requirements

• Bachelor’s degree in life sciences, engineering, business administration, or a related field; an advanced degree is desired.
• 8+ years of experience in the pharmaceutical or biotechnology industry, including at least 3 years in a CMC organization and 2 years supporting regulatory submissions.
• Direct experience supporting or leading BLA and Prior Approval Supplement filings is required.
• Knowledge of CMC manufacturing and analytical activities, cGMP regulations, FDA and ICH requirements, and eCTD Module 3 CMC content.
• Strong planning, tracking, analytical, communication, facilitation, conflict-resolution, and team-management skills.
• Working knowledge of Microsoft Office; familiarity with Veeva and Smartsheet is beneficial.

Nice to have

• PMP certification or formal project management training.
• Experience liaising with external manufacturing organizations.
• Familiarity with Veeva Vault RIM/Submissions and regulatory publishing tools.
• Advanced degree in a relevant field.

Culture & Benefits

• Hybrid work model with regular onsite collaboration.
• Comprehensive employee benefits.
• Equity component included in the compensation package.
• COVID-19 vaccination is required for all employees.
• Equal opportunity employment.