Tyra Biosciences, Inc. is seeking a highly motivated Executive Director of Regulatory Operations 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 Executive Director, Regulatory Operations will lead and scale global regulatory operations for a growing biotechnology organization. This role is responsible for the strategic oversight and flawless execution of regulatory submissions and regulatory systems in support of the company’s development pipeline and commercial goals. Reporting to the Vice President, Regulatory Strategy and Operations, the Executive Director will partner closely with the Regulatory Leads, CMC, Clinical, Quality, and external partners to ensure regulatory excellence, compliance, and operational efficiency across all programs.

This is a critical leadership role for a hands-on regulatory operations expert who thrives in fast-paced environments and is comfortable building processes and capabilities as the organization grows.

Job Responsibilities:

Regulatory Operations Leadership

· Lead global regulatory operations activities across the product lifecycle, including INDs/IMPDs, NDAs/MAAs, amendments, annual reports, and routine maintenance.

· Serve as the primary operational partner to the regulatory leads and RA CMC to ensure submissions are high-quality, compliant, and delivered on time.

Submission Planning and Execution

· Oversee planning, publishing, and delivery of electronic regulatory submissions (eCTD) to global health authorities.

· Manage submission timelines, content coordination, and cross-functional review processes in collaboration with the regulatory leads.

· Ensure consistent interpretation and application of regulatory submission standards across programs and regions.

Systems, Processes, and Compliance

· Own regulatory operations infrastructure, including document management systems, publishing tools, and regulatory information management (RIM) systems.

· Develop, implement, and continuously improve regulatory operations processes, SOPs, and best practices appropriate for a growing biotech company.

· Ensure inspection readiness and compliance with global regulatory requirements and internal quality standards.

Vendor and Resource Management

· Select, manage, and oversee regulatory operations vendors and consultants, including publishing and submission support partners.

· Optimize internal and external resource utilization to meet evolving business needs.

People Leadership and Development

· Build, lead, and mentor a high-performing regulatory operations team.

Cross-Functional and Executive Collaboration

· Foster a culture of accountability, collaboration, and continuous improvement.

· Act as a trusted regulatory operations advisor to senior leadership and cross-functional teams.

· Provide clear, proactive communication on regulatory operations risks, timelines, and execution status.

· Responsible for assigned activities with the project team

· Perform other duties as required

Qualifications

· 12+ years of progressive experience in regulatory operations within the biotechnology or pharmaceutical industry.

· Demonstrated expertise in global regulatory submissions, including eCTD publishing and lifecycle management.

· Strong understanding of FDA, EMA, and other global health authority submission requirements.

· 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

Pay Range and Benefits:

Base Salary Range: $292,363 - $320,871 USD

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

Job Type: Full-Time

Work authorization: United States (Required)

Work Location: Remote flexibility with periodic in-person collaboration

Equal Opportunity Employer: Tyra Biosciences, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity.

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.