Senior Director, Regulatory Affairs UTUC

Tyra Biosciences, Inc. is seeking a highly motivated Senior Director of Regulatory Affairs, UTUC to make impactful contributions to rare disease drug discovery projects targeting disease areas with high unmet medical need. The successful candidate will be highly organized, self-motivated, and thrive in a dynamic, cross functional start-up environment.

The Senior Director, Regulatory Affairs, UTUC will provide strategic regulatory leadership for a late‑stage oncology program in a rapidly growing biotechnology company. Reporting to the Vice President, Regulatory Strategy and Operations, this role is accountable for developing and executing global regulatory strategies that enable timely registration, approval, and lifecycle management of oncology products across major global markets.

This position requires a highly driven regulatory leader with deep global late‑stage and registration experience, proven oncology expertise, and the ability to lead with urgency in a fast‑moving environment.

• Develop and execute comprehensive global regulatory strategies for a late‑stage oncology program, aligned with overall development, registration, and commercialization objectives.
• Lead regulatory strategy from late‑stage development through global submissions, approvals, and post‑approval lifecycle management.
• Anticipate regulatory risks and proactively define mitigation strategies to maintain program momentum.

• Lead global health authority interactions, including FDA, EMA, and other key regions (e.g., PMDA, MHRA, Health Canada, and emerging markets as appropriate).
• Drive preparation for and participation in regulatory meetings (e.g., EOP2, Scientific Advice, pre‑NDA/MAA/JNDA), ensuring clear positioning and alignment across functions.
• Interpret and communicate regulatory feedback and translate it into actionable development and submission plans.

• Serve as the regulatory strategy lead for a cross‑functional oncology program team, providing clear, decisive regulatory guidance.
• Partner closely with cross functional partners to ensure integrated and executable regulatory plans.
• Support accelerated development and registration pathways where applicable (e.g., expedited programs, breakthrough designations).

• Provide strategic oversight for global marketing applications and major lifecycle submissions.
• Ensure global alignment of indication, labeling, and regulatory positioning for oncology assets.
• Guide regulatory input into summary documents and key scientific justifications.

• Lead with urgency, accountability, and focus in a dynamic, high‑growth biotech environment.
• Balance strategic thinking with hands‑on contribution as needed to support critical program milestones.
• Mentor and influence team members and stakeholders, fostering a culture of execution and regulatory excellence.
• Responsible for assigned activities with the project team
• Perform other duties as required

• Bachelor’s degree in a scientific discipline; advanced degree (MS, PhD, PharmD, or MD) strongly preferred.
• 10+ years of progressive experience in global regulatory strategy within the biotechnology or pharmaceutical industry.
• Mandatory experience leading late‑stage development and global registration for oncology products.
• Demonstrated success with major global marketing applications (e.g., NDA/BLA/MAA) and health authority interactions.
• Strong knowledge of global regulatory requirements and pathways for oncology drug development.
• Proven ability to operate with urgency and make sound regulatory decisions in a fast‑paced environment.
• Experience supporting accelerated or innovative…