Senior Director, Regulatory Affairs – Development Strategy (Biopharma)

TL;DR

Senior Director, Regulatory Affairs – Development Strategy (Biopharma): Formulating and implementing global regulatory strategies and plans for efficient product development in serious diseases with an accent on FDA interactions, multinational submissions, and lifecycle management. Focus on identifying regulatory risks, coordinating clinical trial applications, and negotiating with global health authorities.

Location: Fully remote from anywhere (occasional travel ~20% for meetings or events)

Salary: $222,000–$303,000 Annual

Company

Global biopharmaceutical company dedicated to transforming lives of patients with serious and rare diseases.

What you will do

• Lead development and execution of global regulatory strategies for clinical, pre-clinical, and lifecycle activities
• Identify regulatory risks and define mitigation strategies
• Provide guidance on US IND and global CTA submissions
• Direct planning and coordination of regulatory submissions including multinational trials and marketing applications
• Oversee preparation of regulatory agency meeting materials and high-quality presentations
• Monitor global regulatory activities and lead in matrix environment with cross-functional teams

Requirements

• Bachelor’s degree in life sciences or related field + 8+ years in Regulatory Affairs with hands-on multi-region submission experience (US, EU, international)
• Strong knowledge of global regulatory requirements and eCTD formats
• Proven experience managing complex regulatory deliverables across product lifecycle
• Strong submission writing/review skills and significant FDA/EMA interactions
• Deep understanding of drug development process; highly organized, detail-oriented, adaptable

Nice to have

• Advanced degree (MS, PhD, PharmD)
• Experience with orphan drug products
• Experience with inhalation products

Culture & Benefits

• Comprehensive medical, dental, vision, mental health support, wellbeing reimbursement, EAP
• Generous PTO, fertility/family benefits, caregiver support, flexible schedules
• 401(k) with match, equity awards, ESPP, company-paid life/disability insurance
• Learning Institute with LinkedIn Learning, workshops, leadership programs, mentorship
• Employee resource groups, volunteering opportunities