Director, Regulatory Affairs Advertising and Promotion (Biotech)

Location: United States — Remote. Officially documented as full-time work from home, with occasional travel to hirify.global offices or other locations as needed.

Annual salary: $214,100–$264,500 USD, plus eligibility for annual bonus and equity incentives.

Company

hirify.global is a biopharmaceutical company focused on developing innovative medicines for rare diseases and improving access to life-changing treatments.

What you will do

• Chair the Materials Review Committee and provide regulatory expertise for promotional, medical, and payer communications.
• Act as the primary contact with FDA OPDP/APLB and PAAB, responding to agency inquiries and managing advisory review requests.
• Review and approve Form FDA-2253 submissions.
• Provide strategic and operational regulatory guidance for concepts, campaigns, product labeling, and promotional materials.
• Support U.S. and Canadian commercial and medical teams through strategy discussions, meetings, and regulatory guidance.
• Monitor evolving regulations, advisory and enforcement letters, and industry policy trends; lead process improvements and special projects as needed.

Requirements

• BA/BS degree required; an advanced degree such as PharmD, PhD, MS, MBA, or JD is preferred.
• 10+ years of industry experience, including 5+ years in advertising and promotion.
• Experience chairing or leading review committees or other regulatory governance committees.
• Experience participating in cross-functional projects and teams.
• Excellent verbal and written communication, strategic and analytical thinking, attention to detail, and ability to manage multiple priorities.
• Ability to travel when needed.

Nice to have

• Experience with Veeva PromoMats.

Culture & Benefits

• Supportive and inclusive environment focused on learning and professional growth.
• Generous vacation time and company-observed public holidays.
• Volunteer days and employee wellbeing benefits.
• Fitness reimbursement and tuition sponsorship.
• Long-term incentive and employee stock purchase plans or equivalent offerings.
• Professional development plans.