Associate Director, Regulatory Affairs (Biotechnology)

Location: Fully remote; can be performed from anywhere. Occasional domestic and international travel of approximately 10% is expected.

Salary: $164,000–$213,000 annual

Company

hirify.global is a global biopharmaceutical company focused on transforming the lives of patients with serious and rare diseases.

What you will do

• Lead global regulatory strategies for Clinical Trial Applications, Clinical Trial Notifications, INDs, and other clinical trial authorizations.
• Plan and oversee global submissions, amendments, annual maintenance activities, and study closeout requirements.
• Provide regulatory guidance on country-specific requirements and submission pathways.
• Assess protocol amendment impacts and determine amendment classifications according to regional requirements.
• Coordinate with clinical regulatory CROs, regional regulatory experts, subject matter experts, and cross-functional teams.
• Oversee timelines and ensure submission packages are scientifically sound, complete, and compliant.

Requirements

• Bachelor’s degree and 5+ years of Regulatory Affairs experience in the pharmaceutical or biotechnology sector.
• Direct experience creating and managing global CTAs, CTNs, INDs, and other clinical trial authorizations.
• Knowledge of global regulations, ICH guidelines, GCP requirements, and company procedures.
• Strong organizational, planning, follow-up, communication, and cross-functional collaboration skills.
• Ability to meet tight deadlines while working efficiently, flexibly, and with attention to detail.
• High proficiency with Microsoft Office, Adobe Acrobat, and Veeva Vault.

Nice to have

• Advanced degree such as PhD, PharmD, MD, or MS.

Culture & Benefits

• Remote work with occasional purposeful in-person collaboration, team meetings, or events.
• Medical, dental, vision, and mental health support, plus annual wellbeing reimbursement and an Employee Assistance Program.
• Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules.
• 401(k) company match, annual equity awards, Employee Stock Purchase Plan, and company-paid life and disability insurance.
• Learning and development programs, mentorship, networking opportunities, employee resource groups, and service programs.