💼 About This Role

You'll design and implement global regulatory strategies for a late-stage rare disease biopharmaceutical company. You will serve as the corporate liaison with Health Authorities to ensure successful product registrations and lifecycle management. This leadership role offers the chance to impact transformative therapies for severe metabolic and endocrine disorders.

🎯 What You'll Do

• Design and implement global regulatory strategies for product development and marketing.
• Serve as single point of accountability and lead regulatory sub-teams.
• Identify and assess regulatory risks for assigned projects.
• Oversee ex-US regulatory representatives and consultants.
• Liaise with Health Authorities to build effective relationships.

📋 Requirements

• 8-15 years of Regulatory Affairs experience across product lifecycle.
• Experience in major regions: US, EU, Japan, Canada.
• Strong competency in regulatory requirements and emerging landscape.
• Ability to read, analyze, and interpret scientific and technical documents.

✨ Nice to Have

• Advanced degree (MS, PhD, PharmD, MD, JD) in science or healthcare.
• Experience responding to Health Authority inquiries.
• Supervisory experience in regulatory affairs.

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

1. 1Phone Screen· 30 min
2. 2Hiring Manager Interview· 1 hour
3. 3Panel Interview· 2 hours