Manager, Americas Regulatory Affairs Labeling & Promotion, Global Rare Diseases

Location: Remote within the United States; candidates must be based in the Eastern or Central US time zones.

Salary: $121,000–$150,000 annual base pay.

Company

hirify.global is an international research-focused biopharmaceutical group developing and commercializing medicines and patient support services, including treatments for rare and ultra-rare diseases.

What you will do

• Manage the development, revision, and maintenance of core, US, and international product labeling, patient materials, and product artwork.
• Support product development, lifecycle management, clinical programs, and global labeling strategy.
• Lead regulatory review of advertising, promotional materials, disease-state information, and external communications.
• Coordinate submissions of labeling and promotional materials to health authorities, including FDA Form 2253 submissions.
• Participate in promotional risk management, audits, inspections, SOP updates, and regulatory system oversight.
• Collaborate with cross-functional teams, senior management, affiliates, and health authorities.

Requirements

• Bachelor’s degree in life sciences or a related field.
• At least 5 years of relevant experience in regulatory labeling and promotion.
• Experience managing complex multifunctional teams, including regulatory colleagues.
• Knowledge of global and US labeling, advertising, and promotional requirements.
• Experience preparing labeling documents for new drug, biologic, or device applications and reviewing launch advertising materials.
• Project management skills and experience communicating with regulatory authorities on labeling and advertising matters.

Nice to have

• Postgraduate degree in life sciences or a related field.
• RAC or postgraduate master certification.
• Experience preparing for and participating in regulatory health authority meetings.

Culture & Benefits

• Purpose-driven, sustainability-focused biopharmaceutical organization.
• Commitment to diversity, inclusion, equal opportunity, and ethical conduct.
• Healthcare programs and work-life balance initiatives.
• Professional development resources and training.
• Remote and flexible working arrangements, performance bonuses, and relocation support.