Senior Director, Regulatory Affairs – Early Development/ Business Development (Biopharmaceuticals)

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

Salary: $222,000–$303,000 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

• Develop and lead regulatory strategies for early-stage drug development programs from pre-IND through Phase 2.
• Evaluate external assets through regulatory due diligence, including pathways, data packages, risks, mitigation strategies, and value inflection points.
• Provide regulatory recommendations for investment decisions, asset valuation, and development planning.
• Prepare and submit regulatory documents, including pre-IND meeting requests, briefing books, INDs, and amendments.
• Support health authority interactions, meeting strategies, briefing materials, and responses.
• Partner with Clinical, CMC, Nonclinical, Biostatistics, and Program Management teams as a global or regional regulatory lead and primary contact for the US FDA.

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 multiple regions, including the U.S., EU, and/or other international markets.
• Experience supporting early-stage drug development and health authority interactions, including pre-IND and Type B meetings.
• Strong understanding of global regulatory frameworks and the drug development process, with the ability to assess scientific, clinical, and CMC data.
• Strong communication, strategic thinking, organization, prioritization, and cross-functional collaboration 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 connection to the broader team and community.
• Medical, dental, and vision coverage, mental health support, wellbeing reimbursement, and EAP access.
• Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules.
• 401(k) match, annual equity awards, ESPP, and company-paid life and disability insurance.
• Learning programs, mentorship, employee resource groups, recognition programs, and volunteer opportunities.