Senior Director Regulatory Affairs - ACH

Tyra Biosciences, Inc. is seeking a highly motivated Sr. Director of Regulatory Affairs 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 LeadershipDevelop 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 EngagementLead 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 LeadershipServe 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 RegistrationProvide 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 EnvironmentLead 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 teamPerform other duties as required
QualificationsBachelor’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 formatAbility to work both independently with minimal direction and within project teams to attain group goalsHighly detailed with strong organization skillsAbility to work well in a deadline-driven environmentTeam oriented personFluent in spoken and written EnglishUp to 20% travel may be required
Pay Range and Benefits:Base Salary Range: $275,065 - $303,232 USDIndividual 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 packagesThe starting compensation range(s) for this role is for a full-time employee (FTE) basisBenefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollmentEmployer -paid Medical, dental, and vision insuranceEmployer-paid life insurance, AD&D, short-term disability, long-term disability, and EAP coverage401(k) Plan with a fully vested company match 1:1 up to 4% of contributionsEmployee Stock Purchase Plan14 -18 paid holidays, including office closure between December 25th and January 1stFlexible vacationSick timeFitness ProgramGet Outdoors ProgramPaid parental leave benefitTuition assistance
Job Type: Full-TimeWork 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.