Director, Regulatory Affairs (Development Strategy)

TL;DR

Director, Regulatory Affairs (Development Strategy): Providing strategic and operational regulatory leadership for business development and early-stage drug development programs with an accent on regulatory risk assessment and global strategy execution. Focus on serving as the primary regulatory contact for the U.S. FDA and enabling informed investment decisions through cross-functional collaboration.

Location: Must be based in the U.S. (Fully remote)

Salary: $185,000–$252,500 Annual

Company

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

What you will do

• Lead regulatory due diligence assessments for external assets and evaluate regulatory pathways.
• Develop and support global regulatory strategies for assigned pipeline programs.
• Prepare and submit regulatory documents including INDs, briefing books, and meeting requests.
• Provide regulatory input into study design, endpoints, and development plans.
• Act as the primary regulatory contact for the U.S. FDA and support health authority interactions.
• Collaborate cross-functionally with Clinical, CMC, Nonclinical, and Biostatistics teams.

Requirements

• Bachelor’s degree required.
• 5+ years of experience in Regulatory Affairs or related functions.
• Hands-on experience in regulatory submissions across multiple regions (U.S., EU).
• Experience supporting early-stage drug development (pre-IND through Phase 2).
• Ability to travel domestically and internationally (approximately 20%).
• Strong understanding of global regulatory frameworks and drug development processes.

Nice to have

• Advanced degree (PhD, PharmD, MD, MS).
• Experience in regulatory due diligence, business development, or asset evaluation.
• Understanding of PMDA regulatory frameworks.

Culture & Benefits

• Comprehensive medical, dental, and vision coverage with mental health support.
• 401(k) plan with company match and annual equity awards.
• Generous paid time off and flexible work schedules.
• Access to LinkedIn Learning, leadership programs, and mentorship opportunities.
• Supportive culture with employee resource groups and volunteer programs.