Associate Director Regulatory Affairs Strategy

Tyra Biosciences, Inc.

Tyra Biosciences, Inc. is seeking a highly motivated Associate 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.

This leader will be an integral member of a growing Regulatory Affairs team, that will work closely with a cross-functional development team and external vendors and consultants. They will provide strategic and operational support for advancing Tyra’s investigational products in development. They will be responsible for executing regulatory strategy and hands‑on management of regulatory submissions for multiple projects. They will interface with regulatory authorities on specific projects while adapting to changing project priorities.

Job Responsibilities:

• Prepare and submit different types of regulatory applications (e.g. IND’s/CTA’s, briefing books for health authority meetings, PPSR’s/PIPs, orphan designation, annual reports, IND safety reports)
• Work closely with nonclinical, clinical and CMC teams in managing preparation of submissions according to timelines
• Coordinate the preparation of responses to health authority questions
• Partner with the Sr Director to shape and operationalize global regulatory strategy, assess regional considerations (US, EU, Japan), and present clear, decision-ready options and tradeoffs to inform program decisions.
• Manage vendors and consultants to support regulatory submission goals
• Maintain up-to-date knowledge of regulatory requirements and best practices and communicate knowledge of new regulations to team members
• Participate in multidisciplinary study and/or product development teams to manage Regulatory activities related to product development
• Create and manage departmental SOPs and guidelines
• Produce high quality regulatory submissions using electronic publishing systems
• Responsible for assigned activities with the project team
• Perform other duties as required

Qualifications:

• Bachelor’s degree in a scientific field, advanced degree preferred with 4-6 years of Regulatory Affairs or other relevant industry experience
• Experience with pharmaceutical and clinical development of new chemical entities (rare disease preferred)
• Track record of translating complex regulatory considerations into clear implications, risks, and decision-ready tradeoffs.
• Knowledge of FDA and global regulations and guidelines
• Proven organizational skills to successfully plan for and mange simultaneous regulatory submissions while managing the routine of daily maintenance of existing regulatory applications
• Experience with electronic common technical document submissions (eCTD) and database management abilities
• 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 : $194,914 - $211,469 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 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.