Associate Director, Regulatory Affairs

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

Company

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

What you will do

• Develop and execute global regulatory strategies for Clinical Trial Applications, INDs, Clinical Trial Notifications, and other clinical trial authorizations.
• Lead regulatory planning for global submissions, amendments, annual maintenance activities, and study closeout requirements.
• Provide guidance on country-specific requirements and submission pathways to support efficient trial initiation.
• Assess the regulatory impact of protocol amendments and determine whether amendments are substantial or non-substantial.
• Align submission strategies across global regions while addressing local regulatory expectations.
• Oversee submission timelines and ensure packages are scientifically sound, complete, and compliant.

Requirements

• Bachelor’s degree.
• At least 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.
• Strong organizational, planning, follow-up, collaboration, and deadline-management skills.
• Proficiency with Microsoft Office, Adobe Acrobat, and Veeva Vault.
• Willingness to travel domestically and internationally approximately 10% of the time.

Nice to have

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

Culture & Benefits

• Fully remote work with occasional purposeful in-person collaboration and team events.
• Medical, dental, vision, and mental health coverage, plus annual wellbeing reimbursement and an Employee Assistance Program.
• Paid time off, fertility and family-forming benefits, and caregiver support.
• 401(k) plan with company match, annual equity awards, employee stock purchase plan, and company-paid life and disability insurance.
• Access to learning programs, LinkedIn Learning, workshops, mentorship, networking, employee resource groups, and service opportunities.