Global Regulatory Affairs Manager (Biotech)

Location: King of Prussia, Pennsylvania, United States

Company

hirify.global is a global biotherapeutics company developing and delivering medicines for rare and serious diseases, including therapies based on plasma fractionation, recombinant protein technology, and cell and gene therapy.

What you will do

• Plan, direct, and monitor regulatory affairs activities and ensure required permits, licenses, certificates, and authorizations are obtained.
• Develop regulatory plans, cost estimates, schedules, and consistent work processes.
• Monitor regulatory developments and advise management on their potential impact.
• Build relationships with government agencies and regulatory authorities.
• Represent the organization before regulatory, legislative, and industry standards agencies.
• Prepare legal counsel materials, compile registration applications, and maintain regulatory systems and data.

Requirements

• Bachelor’s degree in life science or business.
• 3+ years of regulatory experience in the pharmaceutical industry.
• Experience with biologics regulation is preferred.
• Advanced degree in life science, such as a PhD or MD, or an MBA is advantageous.
• Additional qualifications may apply based on local legal and educational requirements.

Culture & Benefits

• Work within a global organization serving patients in more than 100 countries.
• Benefits are provided through CSL’s employee well-being program.
• Inclusive workplace focused on belonging, curiosity, empathy, and diverse perspectives.