Global Regulatory Affairs Manager (Biotechnology)

Location: King of Prussia, Pennsylvania, United States

Company

hirify.global is a global biotechnology company developing and delivering lifesaving medicines, vaccines, and therapies across more than 100 countries.

What you will do

• Plan, direct, and monitor regulatory affairs activities supporting permits, licenses, certificates, authorizations, and other approvals.
• Develop consistent regulatory roles, work processes, plans, cost estimates, and schedules.
• Acquire required permits and approvals and maintain regulatory systems and data.
• Monitor regulatory developments and advise management on their potential business impact.
• Build relationships with government agencies and regulatory authorities and represent organizational interests before regulatory, legislative, and industry standards agencies.
• Prepare materials for legal counsel and external consultants and compile registration application documentation.

Requirements

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

Culture & Benefits

• Work within a global biotechnology organization serving patients in more than 100 countries.
• Focus on innovation across plasma fractionation, recombinant protein technology, and cell and gene therapy.
• Inclusive culture centered on curiosity, empathy, and belonging.
• Employee benefits are provided through hirify.global’s well-being program.