Associate Director, Global Regulatory Advertising and Promotion

Location: Cambridge, Massachusetts, United States; 70% in-office work model. Only U.S. persons are eligible due to U.S. export control requirements.

Salary: $142,500–$256,500 annually, with potential bonus, incentive compensation, or equity award.

Company

hirify.global develops mRNA technologies and medicines through a biotechnology platform focused on reimagining how medicines are created and delivered.

What you will do

• Review and approve promotional materials, corporate communications, and disease awareness campaigns for FDA and applicable regulatory compliance.
• Guide advertising and promotion strategy during early product development.
• Lead assigned product discussions in Promotional Material Review Team and Medical Review Committee processes.
• Collaborate with Marketing, Medical, Legal, Compliance, and Commercial stakeholders.
• Support FDA APLB and other health authority interactions, including 2253 filings and advisory comments requests.
• Develop promotional regulation training and improve SOPs, review processes, and risk monitoring.

Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field.
• At least 5 years of Regulatory Affairs experience, including 2 years focused on advertising and promotion in pharmaceutical, biotech, or medical device industries.
• Deep knowledge of U.S. and global regulatory frameworks, FDA regulations, OPDP/APLB guidance, and enforcement trends.
• Experience working with cross-functional review committees in a regulated environment.
• Strong regulatory writing, communication, problem-solving, attention to detail, and project management skills.
• Must qualify as a U.S. person to access export-controlled information; non-U.S. persons cannot be sponsored for an export control license.

Nice to have

• PharmD, JD, or Master’s degree in Regulatory Affairs.
• Knowledge of EMA, Health Canada, UK, or other global regulatory requirements.
• Experience with digital and social media promotional compliance.
• Experience in infectious diseases, oncology, rare diseases, or vaccines.

Culture & Benefits

• 70/30 in-office work model emphasizing collaboration, innovation, and mentorship.
• Healthcare coverage and voluntary benefit programs.
• Fitness, mindfulness, and mental health resources.
• Family planning benefits, including fertility, adoption, and surrogacy support.
• Paid vacation, volunteer days, sabbatical, global recharge days, and year-end shutdown.
• Savings and investment programs, plus location-specific benefits.