Global Regulatory Director – Oncology (Remote)

Tyra Biosciences, Inc.; United States; Remote; USD 275,000 - 303,000; Full time

Benefits offered by this job

Employer-paid Medical, dental, and…

401(k) Plan with company match

Employee Stock Purchase Plan

Paid holidays

Flexible vacation

Tuition assistance

Job summary

Tyra Biosciences, Inc. seeks a Senior Director of Regulatory Affairs, UTUC to provide strategic regulatory leadership for a late-stage oncology program in a fast-growing biotech.

You will report to the Vice President, Regulatory Strategy and Operations and drive global regulatory strategies enabling timely registration and lifecycle management. The candidate will lead health authority engagements, guide cross-functional teams, and support accelerated pathways where applicable.

Qualifications

• 10+ years of global regulatory strategy experience in biotech/pharma.
• Mandatory experience leading late-stage development and global registration for oncology products.
• Proven success with major global marketing applications and health authority interactions.
• Strong knowledge of global regulatory requirements for oncology drug development.
• Ability to lead teams and manage complex regulatory programs in a fast-paced environment.

Responsibilities

• Develop and execute global regulatory strategies for a late-stage oncology program.
• Lead regulatory strategy from late-stage development through submissions and lifecycle management.
• Anticipate regulatory risks and define mitigation strategies to maintain momentum.
• Lead global health authority interactions (FDA, EMA, PMDA, MHRA, Health Canada).
• Prepare for regulatory meetings and translate feedback into actionable plans.
• Serve as regulatory strategy lead for cross-functional oncology program teams.
• Support accelerated development and expedited pathways where applicable.
• Provide strategic oversight for global marketing applications and major submissions.
• Guide regulatory input into study summaries and scientific justifications.

Skills

Regulatory strategy

Oncology leadership

Global submissions

Health authority engagement

Cross-functional leadership

Program lifecycle management

Urgency driven decisions

Team mentorship

Vendor management

Regulatory strategy for late-stage

Education

Bachelor's in a scientific field

MS/PhD/PharmD/MD preferred

Job description

Tyra Biosciences, Inc. seeks a Senior Director of Regulatory Affairs, UTUC to provide strategic regulatory leadership for a late-stage oncology program in a fast-growing biotech.

You will report to the Vice President, Regulatory Strategy and Operations and drive global regulatory strategies enabling timely registration and lifecycle management. The candidate will lead health authority engagements, guide cross-functional teams, and support accelerated pathways where applicable.