Regulatory Strategy Lead — Global Submissions & Lifecycle

BioCryst Pharmaceuticals, Inc.; North Carolina; Vor Ort; USD 140.000 - 190.000; Vollzeit

Zusammenfassung

BioCryst Pharmaceuticals, Inc. seeks an Associate Director of Regulatory Affairs Strategy to shape regulatory plans for our rare disease programs.

You will lead global strategies, coordinate IND/BLA submissions, and partner with development teams to align regulatory and clinical goals. The role requires a strong track record in biotech/pharma regulatory strategy, excellent communication, and a global mindset.

Qualifikationen

• Bachelor’s degree required; advanced degree a plus.
• 8–10 years regulatory strategy experience in biotech/pharma.
• Strong communication, organizational, and teamwork skills.
• Solid knowledge of US FDA regulations with global exposure.

Aufgaben

• Lead global regulatory strategy for advanced programs.
• Oversee IND, BLA/NDA submissions and post-approval activities.
• Coordinate with cross-functional teams and external partners.
• Serve as Global Regulatory Lead on defined projects when needed.
• Develop and refine SOPs to ensure regulatory compliance.
• Monitor timelines and communicate risks to leaders.

Kenntnisse

Regulatory strategy

Leadership

Cross-functional collaboration

Ausbildung

Bachelor’s degree

MS/PhD preferred

Jobbeschreibung

BioCryst Pharmaceuticals, Inc. seeks an Associate Director of Regulatory Affairs Strategy to shape regulatory plans for our rare disease programs.

You will lead global strategies, coordinate IND/BLA submissions, and partner with development teams to align regulatory and clinical goals. The role requires a strong track record in biotech/pharma regulatory strategy, excellent communication, and a global mindset.