Sr Director, Regulatory Affairs Strategy (Rare Disease)

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

Benefits offered by this job

Competitive base salary

Annual bonus

Equity package

Employer-paid medical, dental, vision

401(k) with company match

Paid holidays

Tuition assistance

Job summary

Tyra Biosciences, Inc. seeks a Sr. Director of Regulatory Affairs Strategy to lead global regulatory plans for a late‑stage Skeletal Dysplasia program. You will guide submissions, align labeling, and drive lifecycle strategies across major markets.

You will engage with FDA/EMA and other authorities, mentor cross‑functional teams, and accelerate development where appropriate in a fast‑growing biotech setting.

Qualifications

• Bachelor's degree in a scientific discipline; advanced degree strongly preferred.
• 10+ years of progressive global regulatory strategy experience in biotech/pharma.
• Experience leading late-stage development and global registration for Skeletal Dysplasia products.
• Proven success with major global marketing applications (NDA/BLA/MAA) and health authority interactions.
• Ability to operate with urgency and make sound regulatory decisions in a fast-paced environment.

Responsibilities

• Develop and execute global regulatory strategies for a late-stage Skeletal Dysplasia program.
• Lead regulatory strategy from late-stage development through global submissions and lifecycle management.
• Engage with health authorities (FDA, EMA, PMDA, MHRA, Health Canada) and prepare for meetings.
• Lead cross-functional teams, mentor staff, and support accelerated regulatory pathways.

Skills

Regulatory strategy

Global submissions

Leadership and mentoring

Cross-functional collaboration

Regulatory risk management

Regulatory policy knowledge

Effective communication

Agile / fast-moving environment

Strategic planning

Travel readiness

Education

Bachelor’s degree in a scientific discipline

MS/PhD/PharmD/MD preferred

Job description

ABOUT THE JOB

Tyra Biosciences, Inc. is seeking a highly motivated Sr. Director of Regulatory Affairs Strategy 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 Sr. Director, Regulatory Affairs will provide strategic regulatory leadership for a late‑stage Skeletal Dysplasia 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 Skeletal Dysplasia products across major global markets. This position requires a highly driven regulatory leader with deep global late‑stage and registration experience, proven Skeletal Dysplasia 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 Skeletal Dysplasia 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.

Skeletal Dysplasia Program Leadership

• Serve as the regulatory strategy lead for a cross‑functional Skeletal Dysplasia 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 Skeletal Dysplasia 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 Skeletal Dysplasia 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 Skeletal Dysplasia 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 Skeletal Dysplasia.
• 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 USD

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

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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.