Global Regulatory Strategy Lead

BioCryst Pharmaceuticals; North Carolina; On-site; USD 130,000 - 180,000; Full time

Job summary

BioCryst Pharmaceuticals seeks an Associate Director, Regulatory Affairs Strategy to partner with product development teams and guide regulatory strategy and submissions worldwide. The role leads development efforts, aligns with global regulations, and collaborates across functions to optimize timelines.

The position emphasizes lifecycle management, post-approval activities, and strong communication to advance programs while maintaining high ethical standards and a focus on US FDA requirements.

Qualifications

• Bachelor's degree required with advanced degree (MS; PhD, PharmD) a plus
• Eight (8) to ten years regulatory strategy experience in the biotech/pharmaceutical industry
• Ability to maintain high ethical standards
• Excellent organizational skills, attention to details, and communication skills
• Ability to work as part of a team, both in a leadership role on assigned duties and as a contributing member of the company
• Ability to develop and maintain positive working relationships across cross‑functional teams
• Strong interpersonal skills with demonstrated ability to serve as a strong, collaborative partner with internal and external stakeholders and effective written and verbal communication and presentation skills
• Thorough knowledge of US FDA regulations, with Global experience a plus, regarding product development (IND/CTA), BLA/NDA/MAA with a sense of curiosity driving continuous learning and program success
• Effective written and verbal communication, presentation skills and computer literate (e.g., MS Word, MS PowerPoint, MS Excel)

Responsibilities

• With Director oversight, manage initial global approvals and post-approval activities for advanced programs with partners
• Support lifecycle management submissions in US and international markets
• Develop regulatory strategies by researching regulations for global alignment
• Compile, prepare and submit IND, BLA/NDA filings and related documents
• Serve as Global Regulatory Lead for defined projects and coordinate workstreams
• Coordinate Health Authority meetings and regulatory deliverables
• Review/Revise SOPs to ensure compliance with Global Regulations
• Manage regulatory timelines and flag risks to leadership
• Maintain current knowledge of FDA regulations and global guidelines
• Perform additional duties as assigned

Skills

Regulatory strategy

Cross-functional leadership

Communication skills

Team collaboration

Presentation skills

Education

Bachelor's degree

MS/PhD/PharmD (advanced degree)

Tools

MS Word

MS PowerPoint

MS Excel

Job description

BioCryst Pharmaceuticals seeks an Associate Director, Regulatory Affairs Strategy to partner with product development teams and guide regulatory strategy and submissions worldwide. The role leads development efforts, aligns with global regulations, and collaborates across functions to optimize timelines.

The position emphasizes lifecycle management, post-approval activities, and strong communication to advance programs while maintaining high ethical standards and a focus on US FDA requirements.