Associate Director Regulatory Affairs Strategy

Skip to main content Associate Director Regulatory Affairs Strategy Tyra Biosciences United States Apply Associate Director Regulatory Affairs Strategy Tyra Biosciences United States 1 week ago 108 applicants See who Tyra Biosciences has hired for this role Apply Save Report this job Use AI to assess how you fit Get AI-powered advice on this job and more exclusive features. Am I a good fit for this job? Tailor my resume Sign in to access AI-powered advices Email or phone Password Show Forgot password? Sign in Sign in with Email or New to LinkedIn? Join now By clicking Continue to join or sign in, you agree to LinkedIn’s User Agreement, Privacy Policy, and Cookie Policy. Sign in to evaluate your skills Email or phone Password Show Forgot password? Sign in Sign in with Email or New to LinkedIn? Join now By clicking Continue to join or sign in, you agree to LinkedIn’s User Agreement, Privacy Policy, and Cookie Policy. Sign in to tailor your resume Email or phone Password Show Forgot password? Sign in Sign in with Email or New to LinkedIn? Join now By clicking Continue to join or sign in, you agree to LinkedIn’s User Agreement, Privacy Policy, and Cookie Policy. 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 timelinesCoordinate the preparation of...