Senior Director, Regulatory Affairs Strategy (Oncology - UTUC)

About the Role

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.

Job Responsibilities:

Global Regulatory Strategy Leadership

• 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.

Health Authority Engagement

• 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.

Oncology Program Leadership

• 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).

Submissions and Registration

• 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.

Leadership in a Fast‑Paced Environment

• 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

Qualifications

• 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 regulatory pathways in oncology.

• Prior experience working on cross‑regional global regulatory strategies.

• Proven ability to lead teams, manage vendors, and execute complex regulatory programs in a dynamic environment.

• Experience supporting both late‑stage development and early commercial products.

• Prior experience in a high‑growth or emerging biotech environment.

• Direct experience building or scaling regulatory operations capabilities.

• Ability to communicate effectively in both a written and verbal format

• Ability to work both independently with minimal direction and within project teams to attain group goals

• Highly detailed with strong organization skills

• Ability to work well in a deadline-driven environment

• Team oriented person

• Fluent in spoken and written English

• Up to 20% travel may be required

Base Salary Range: $275,065 - 303,232

Individual compensation will be determined based on factors such as work location, skills, education, training, and experience.

What we offer US-based Employees

• Competitive base, bonus, new hire and ongoing equity packages

• The starting compensation range(s) for this role is for a full-time employee (FTE) basis

• Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment

• Employer-paid Medical, dental, and vision insurance

• Employer-paid life insurance, AD&D, short-term disability, long-term disability, and EAP coverage

• 401(k) Plan with a fully vested company match 1:1 up to 4% of contributions

• Employee Stock Purchase Plan

• 14 -18 paid holidays, including office closure between December 25th and January 1st

• Flexible vacation

• Sick time

• Fitness Program

• Get Outdoors Program

• Paid parental leave benefit

• Tuition assistance

Equal Opportunity Employer

Tyra Biosciences is an equal opportunity employer committed to building a diverse and inclusive workforce. Employment decisions are made without regard to race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information, gender identity or expression, veteran status, or any other characteristic protected by applicable federal, state, or local laws.

Notice to Recruiters and Third-Party Agencies

The Talent Acquisition team manages the recruitment and employment process for Tyra. To protect the interests of all parties involved, Tyra will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Tyra employees directly in an attempt to present candidates. Tyra will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees.