Global Regulatory Strategy Director (Remote)

BioCryst Pharmaceuticals, Inc.; Northern (KY); Hybrid; USD 140,000 - 190,000; Full time

Job summary

BioCryst Pharmaceuticals is seeking an Associate Director of Regulatory Affairs Strategy to shape regulatory pathways for innovative programs. You will partner with product development teams to craft strategies and submissions globally while ensuring timely approvals.

The role requires strong cross-functional collaboration, leadership in regulatory science, and deep knowledge of FDA regulations with global experience a plus. Join a company dedicated to rare diseases and impactful medicines.

Qualifications

• Bachelor’s degree required; advanced degree (MS; PhD, PharmD) a plus.
• 8–10 years regulatory strategy experience in biotech/pharmaceutical industry.
• Thorough knowledge of US FDA regulations; global experience a plus.

Responsibilities

• Manage initial global approvals and post-approval activities for advanced programs with partnering companies.
• Support lifecycle management submissions in the US and internationally; assist development projects.
• Prepare and submit IND, BLA/NDA and other US regulatory filings; coordinate with GRL as needed.
• Lead workstreams and coordinate Health Authority meetings; track status of regulatory submissions.

Skills

Regulatory strategy

FDA regulations

Cross-functional teamwork

Written & verbal communication

Project leadership

Education

Bachelor’s degree

MS/PhD/PharmD preferred

Job description

BioCryst Pharmaceuticals is seeking an Associate Director of Regulatory Affairs Strategy to shape regulatory pathways for innovative programs. You will partner with product development teams to craft strategies and submissions globally while ensuring timely approvals.

The role requires strong cross-functional collaboration, leadership in regulatory science, and deep knowledge of FDA regulations with global experience a plus. Join a company dedicated to rare diseases and impactful medicines.