Senior Director, Regulatory Affairs, Global Regulatory Lead – Development Strategy (Biotech)

TL;DR

Senior Director, Regulatory Affairs, Global Regulatory Lead – Development Strategy (Biotech): Formulating and implementing global regulatory strategies and plans for efficient product development in serious and rare diseases with an accent on clinical, pre-clinical, and lifecycle management activities. Focus on directing regulatory submissions, providing input to cross-functional teams, acting as primary FDA contact, and negotiating with global health authorities.

Location: Fully remote from anywhere. Occasional travel for team meetings or events (approximately 20%).

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 assigned programs.
• Identify regulatory risks, define mitigation strategies, and provide guidance across R&D functions.
• Direct planning and coordination of global regulatory submissions, including IND, CTA, and marketing applications.
• Oversee preparation of regulatory submissions and materials for agency meetings.
• Monitor global regulatory activities and assess impact on company programs.
• Collaborate with regional leads and cross-functional teams in a matrix environment.

Requirements

• Bachelor’s degree in life sciences or related field + 8+ years in Regulatory Affairs with hands-on experience in submissions across US, EU, and international markets.
• 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 interactions with FDA, EMA, and other agencies.
• Deep understanding of drug development process; highly organized, detail-oriented, adaptable self-starter able to manage tight deadlines.

Nice to have

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

Culture & Benefits

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