Senior Director, Regulatory Affairs - Early Development/Business Development (Biopharmaceutical)

Location: Fully remote; can be performed from anywhere. Occasional domestic, international, and global travel of approximately 20% is expected.

Company

hirify.global is a global biopharmaceutical company developing treatments for patients with serious and rare diseases.

What you will do

• Develop and lead regulatory strategies for early development programs from pre-IND through Phase 2.
• Assess nonclinical, clinical, and CMC data packages, identifying gaps, risks, and value inflection points.
• Represent Regulatory Affairs in due diligence and asset evaluation activities, providing recommendations for development and valuation decisions.
• Prepare regulatory documents, including pre-IND meeting requests, briefing books, INDs, and amendments.
• Support health authority interactions through meeting strategies, briefing materials, and response development.
• Partner with Clinical, CMC, Nonclinical, Biostatistics, and Program Management teams to align regulatory, clinical, and development plans.

Requirements

• Advanced degree such as PhD, PharmD, or MS.
• 10+ years of experience in Regulatory Affairs or related functions.
• Hands-on experience with regulatory submissions across the U.S., EU, and/or other international markets.
• Experience supporting early-stage drug development, regulatory submissions, and health authority interactions.
• Strong understanding of global regulatory frameworks, drug development processes, and scientific, clinical, and CMC data.
• Strong communication, strategic thinking, cross-functional collaboration, organization, and prioritization skills.

Nice to have

• Experience in regulatory due diligence, business development, or asset evaluation.
• Knowledge of FDA and EMA frameworks; PMDA experience is a plus.

Culture & Benefits

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