Lyra Therapeutics, Inc. is a clinical-stage biotechnology company developing novel, integrated drug and delivery solutions for the localized treatment of patients with chronic rhinosinusitis (CRS) and other chronic diseases. Lyra has two investigational product candidates, LYR-210 and LYR-220, in late-stage development for CRS, a highly prevalent inflammatory disease of the paranasal sinuses which leads to debilitating symptoms and significant morbidities. LYR-210 and LYR-220 are bioresorbable polymeric matrices designed to be administered in a brief, non-invasive, in-office procedure and are intended to deliver up to six months of continuous mometasone furoate drug therapy to the sinonasal passages as an alternative to sinus surgery. LYR-210 is designed for surgically naïve patients and is being evaluated in the ENLIGHTEN Phase 3 clinical program, while LYR-220, an enlarged matrix, is being evaluated in patients who have recurrent symptoms despite surgery in the BEACON Phase 2 clinical trial.  These two product candidates are designed to treat the estimated four million CRS patients in the United States who fail medical management each year. For more information, please visit www.lyratherapeutics.com and follow us on LinkedIn and Twitter.

We are seeking a Sr. Director of Regulatory to provide strategic direction and regulatory support for the development and market approval of Lyra’s therapeutic products through the FDA’s 505(b)(2) pathway.  The ideal candidate will be a hands-on self-starter and a creative thinker, with the ability to collaborate and work cohesively with internal team members and external collaborators. The Sr. Director will report to the SVP, Regulatory.

Responsibilities

• Manage US and EU regulatory submissions for Lyra’s products
• Prepare and oversee submissions including, but not limited to IND, CTA, NDA/MAA,  and health authority interactions
• Provide oversight to the global regulatory activities ?that are performed by our Clinical Research Organization (CROs) and regulatory vendor
• Contribute to the development of a regulatory strategy for Lyra’s product pipeline, including assessment of key guidance documents and regulations
• Act as direct liaison with FDA and other regulatory agencies as directed by the Senior Vice President, Regulatory Affairs 
• Handle regulatory operations 
• Advise senior management and stakeholders of regulatory requirements for CMC, Preclinical and Clinical in order to meet business objectives according to aggressive timelines
• Collaborate with SVP, Regulatory in the areas of department structure, including short and long-term goals and the department budget
• Represent Regulatory Affairs on internal project teams
• Mentor junior staff in the regulatory team to support their development and enable program deliverables

• Bachelor’s degree and 10+ years of regulatory experience
• Experience with drug/device combination products and 505(b)(2) NDA submissions are essential
• Proven ability to manage drug and drug/device combination product regulatory submissions (e.g., original RFD, IND/IND amendments, NDA in eCTD format)
• Experience throughout product lifecycle, from development through FDA approval, including direct experience with the FDA
• Strong knowledge of FDA regulations, ICH guidelines, GMP, GLP and GCP practices 
• Excellent verbal and written communication skills
• Ability to work independently to meet aggressive timelines
• Organizational and project management skills
• Team player with strong interpersonal skills and the ability to effectively interact with cross-functional teams including medical, scientific, manufacturing and commercial

At Lyra, we value creativity, leadership, and collaboration.  The company sees significant expansion opportunities for our platform, and look for people who are driven to succeed, innovative, and adaptable.  We offer a competitive compensation and benefit package with opportunities to join a fast-paced, high performing team.  For consideration please submit cover letter and CV.