Global Regulatory Affairs Director - Submissions & Strategy

spyretherapeutics; United States; On-site; USD 190,000 - 260,000; Full time

Benefits offered by this job

Equity grant opportunities

Bonus program

Unlimited PTO

Company-wide shutdowns

Job summary

Spyre Therapeutics in the United States seeks a strategic Director of Regulatory Affairs to lead global regulatory activities for one or more drug candidates, with initial focus on the IBD program. You will drive regulatory strategy, submissions, and health authority engagement to enable clinical trials and eventual approvals.

You will coordinate cross-functional teams across Preclinical, CMC, Clinical Development, Legal, and Quality, manage budgets, and mentor regulatory staff while staying

Qualifications

• Bachelor’s degree in life sciences or related field; advanced degree preferred.
• 8–10 years of experience in pharmaceutical regulatory affairs or related disciplines.
• Proven track record in managing complex regulatory submissions and global submissions.

Responsibilities

• Develop and implement regulatory strategies enabling clinical trials and marketing applications.
• Prepare, review, and submit regulatory applications and dossiers to health authorities.
• Plan and lead health authority meetings; develop briefing materials and capture actions.
• Represent the company in regulatory interactions with agencies worldwide.
• Identify regulatory risks and mitigate them; monitor regulatory changes.
• Maintain regulatory intelligence and adapt strategies accordingly.
• Collaborate across Pre-clinical, Clinical Development, Quality, Legal, and Ops.
• Contribute to regulatory budget development and management.

Skills

Regulatory strategy

Regulatory submissions

Health authority meetings

Communication

Risk management

Regulatory intelligence

Cross-functional collaboration

Budget management

Leadership

Problem-solving

Education

Bachelor's degree in life sciences

Tools

Regulatory software

Document management systems

MS Office

Job description

Spyre Therapeutics in the United States seeks a strategic Director of Regulatory Affairs to lead global regulatory activities for one or more drug candidates, with initial focus on the IBD program. You will drive regulatory strategy, submissions, and health authority engagement to enable clinical trials and eventual approvals.

You will coordinate cross-functional teams across Preclinical, CMC, Clinical Development, Legal, and Quality, manage budgets, and mentor regulatory staff while staying