🛠 Tech Stack

💼 About This Role

You'll lead global regulatory submission strategies for a diverse portfolio of rare disease therapies, ensuring timely, high-quality regulatory filings. This high-impact role offers strong organizational visibility and the chance to influence processes in a collaborative biotech environment.

🎯 What You'll Do

• Lead regulatory filing subteams ensuring alignment and execution across programs.
• Develop and maintain detailed regulatory project timelines using Smartsheet or Microsoft Project.
• Monitor submission milestones across Regulatory, Clinical, CMC, and Nonclinical functions.
• Identify operational risks and drive continuous improvement of regulatory processes.

📋 Requirements

• 8–10+ years of experience in regulatory project management or pharmaceutical/biotech project management.
• Bachelor’s degree in a related scientific or technical field.
• Strong knowledge of global regulatory requirements and submission processes.
• Hands-on experience managing original marketing applications and lifecycle submissions.

✨ Nice to Have

• PMP certification.
• Experience with Veeva Vault RIM or One Pager.
• Experience in rare disease or biotech settings.

🎁 Benefits & Perks

• 🏖️ Fully remote work environment with occasional travel.
• 💰 Competitive salary $217,000–$268,100 annually.
• 📈 Annual bonus and equity incentive programs.
• 🎓 Tuition sponsorship and professional development opportunities.
• 💪 Comprehensive wellbeing programs including fitness reimbursement.

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

1. 1Recruiter Screen· 30 min
2. 2Hiring Manager Interview· 60 min
3. 3Panel Interview· 60 min