Global Regulatory Strategy Lead

Regulatory Jobs; North Carolina; On-site; USD 140,000 - 200,000; Full time

Job summary

BioCryst Pharmaceuticals, headquartered in Durham, NC, seeks an Associate Director, Regulatory Affairs Strategy to partner with product development teams and shape regulatory goals. You will craft efficient regulatory strategies and contribute to submissions for BioCryst's programs, aligning regulatory plans with the company's development missions.

You will lead global submissions, lifecycle management, and Health Authority interactions while mentoring subteams and coordinating across regions to

Qualifications

• Bachelor’s degree required; MS/PhD/PharmD a plus.
• 8–10 years regulatory strategy experience in biotech/pharmaceutical industry.
• Strong knowledge of US FDA regulations; global experience a plus.
• Excellent organizational skills, attention to detail, and communication skills.
• Ability to lead and work with cross-functional teams; strong collaborative skills.
• Effective written and verbal communication and presentation skills.

Responsibilities

• Manage initial global approvals and post-approval activities for advanced programs with partnering companies.
• Support lifecycle management submissions for US and international markets; assist development projects.
• Develop regulatory strategies aligned with regional requirements and on-time submissions.
• Prepare IND, BLA/NDA filings and related US regulatory documents.
• May serve as Global Regulatory Lead (GRL) for defined projects and coordinate teams.
• Coordinate Health Authority meetings and provide strategic input.
• Draft and revise SOPs to ensure compliance with global regulations.

Skills

Regulatory strategy

Leadership

Cross-functional teamwork

Regulatory submissions

FDA knowledge

Communication

Education

Bachelor's degree

Advanced degree preferred

Tools

MS Word

MS PowerPoint

MS Excel

Job description

BioCryst Pharmaceuticals, headquartered in Durham, NC, seeks an Associate Director, Regulatory Affairs Strategy to partner with product development teams and shape regulatory goals. You will craft efficient regulatory strategies and contribute to submissions for BioCryst's programs, aligning regulatory plans with the company's development missions.

You will lead global submissions, lifecycle management, and Health Authority interactions while mentoring subteams and coordinating across regions to