Director, Regulatory Affairs (Fully Remote)

Spyre Therapeutics; United States; Remote; USD 140,000 - 200,000; Full time

Job summary

Spyre Therapeutics, Inc. in the United States is seeking a senior Regulatory Affairs professional to manage global regulatory activities for their IBD program, shaping strategies to enable clinical trials and marketing applications.

You will lead preparation and submission of regulatory applications to the FDA, EMA, and other health authorities, ensuring timely approvals while coordinating with research, clinical, and technical teams.

Responsibilities

• Manage global regulatory affairs activities for Spyre's IBD program, developing strategies to enable clinical trials and marketing applications.
• Lead preparation and submission of regulatory applications to FDA, EMA, and other global health authorities, ensuring timely approvals.
• Collaborate cross-functionally with research, clinical, and technical teams to integrate regulatory considerations and mitigate risks.

Job description

• Manage global regulatory affairs activities for Spyre's IBD program, developing strategies to enable clinical trials and marketing applications.
• Lead preparation and submission of regulatory applications to FDA, EMA, and other global health authorities, ensuring timely approvals.
• Collaborate cross-functionally with research, clinical, and technical teams to integrate regulatory considerations and mitigate risks.