Director, Regulatory Affairs - Remote, Global Submissions

Regulatory Jobs; United States; Hybrid; USD 220.000 - 245.000; Vollzeit

Benefits dieser Stelle

Unlimited PTO

Company shutdowns

Remote work with in-person meetings

Equity opportunities

Competitive compensation and benefits

Professional development

Zusammenfassung

Spyre is seeking a Director, Regulatory Affairs to lead regulatory strategy and execution for the company, initially focused on the IBD program. You will plan and manage submissions to global regulators and guide cross-functional teams through clinical development milestones.

You will drive health authority interactions, risk management, and regulatory intelligence, shaping how we advance products toward approval while coordinating with Pre-clinical, Clinical, and Quality functions.

Qualifikationen

• Bachelor’s degree with 8-10 years of experience in pharmaceutical regulatory affairs or related disciplines.

Aufgaben

• Develop and implement regulatory strategies to enable clinical trials and marketing applications.
• Prepare, review, and submit regulatory applications and dossiers to health authorities (FDA, EMA, PMDA, etc.).
• Plan and lead health authority meetings and develop briefing materials.
• Communicate with regulatory agencies and cross-functional teams.
• Identify regulatory risks and develop mitigation strategies.
• Stay current with evolving regulations and best practices in pharma.

Kenntnisse

Leadership

Communication

Interpersonal skills

Problem solving

Ability to meet deadlines

Regulatory affairs software

Ausbildung

Bachelor’s degree

Tools

Regulatory affairs software

Document management systems

Jobbeschreibung

Spyre is seeking a Director, Regulatory Affairs to lead regulatory strategy and execution for the company, initially focused on the IBD program. You will plan and manage submissions to global regulators and guide cross-functional teams through clinical development milestones.

You will drive health authority interactions, risk management, and regulatory intelligence, shaping how we advance products toward approval while coordinating with Pre-clinical, Clinical, and Quality functions.