GRA CMC Specialist (Biotechnology)

Location: King of Prussia, Pennsylvania, United States

Company

hirify.global is a global biotechnology company developing and delivering therapies, vaccines, and other products across rare diseases, influenza, iron deficiency, and nephrology.

What you will do

• Develop global regulatory CMC strategies for capital expenditure, compliance, development, registration, and lifecycle-management projects.
• Coordinate regulatory CMC activities across Global Regulatory Affairs, R&D, Quality, Global Operations, and other business functions.
• Assess and implement digital innovation, including AI/ML applications supporting regulatory submissions, notifications, assessments, and intelligence.
• Manage outsourcing vendors and external partners, monitoring deliverables, timelines, quality, KPIs, compliance, and regulatory readiness.
• Monitor and communicate evolving FDA, EMA, PMDA, NMPA, and other global CMC regulations.
• Support change control, due diligence, CTD template management, deviation and inspection activities, policy development, and strategic planning.

Requirements

• Bachelor’s degree in biological or chemical sciences or a related field; an MS or PhD is preferred.
• More than five years of progressive regulatory experience in the biologics or plasma industry.
• In-depth knowledge of global regulations and international standards for drug product development, manufacturing, registration, and lifecycle management.
• Experience authoring, reviewing, and managing regulatory submissions at federal and state levels.
• Ability to lead cross-functional teams, influence stakeholders, negotiate, and communicate regulatory positions effectively.
• Experience motivating and mentoring diverse teams in a matrixed organization, with a strong focus on compliance and accountability.

Culture & Benefits

• Work with cross-functional and international stakeholders on strategic regulatory initiatives.
• Focus on inclusion, belonging, curiosity, empathy, integrity, and collaboration.
• Benefits information is provided through hirify.global’s employee well-being program.
• Equal opportunity employer with reasonable accommodation available during the application process.