Director, Regulatory Affairs

Benefits:

• 401(k) matching
• Bonus based on performance
• Competitive salary
• Dental insurance
• Health insurance
• Opportunity for advancement
• Paid time off
• Parental leave
• Stock options plan
• Vision insurance
• Wellness resources

Director, Regulatory Affairs

Company Overview:

Avalyn Pharma is developing innovative, inhaled therapies to target the lungs for treatment of rare respiratory diseases, including idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). Avalyn completed an oversubscribed $175M Series C financing in September 2023 to advance our clinical-stage pulmonary fibrosis portfolio consisting of inhaled pirfenidone (AP01), inhaled nintedanib (AP02), and a fixed-dose combination of both (AP03). Currently, treatment for IPF and PPF includes the oral antifibrotics, pirfenidone and nintedanib. Due to side effects, 30-50% of patients cannot tolerate these medications. Avalyn has developed inhaled formulations for these FDA-approved antifibrotics. AP01 has now been studied in over 150 patients with various forms of pulmonary fibrosis, over at least 48 weeks and some out to 4 years and is phase 2b ready. PK studies show that AP01 reaches 35 times the concentration in the lung with 1/15th of the systemic concentration compared to historic oral pirfenidone. AP01 has demonstrated efficacy in the ATLAS study, with a high dose achieving near stabilization of lung function and is well tolerated with fewer systemic adverse events vs. historic oral pirfenidone. We have also completed a phase 1a study of AP02, an inhaled formulation of nintedanib, with phase 1b & 2 plans being developed. Phase 1a positive topline results were announced in March 2023, and AP02 was demonstrated to be safe and well tolerated in normal volunteers & IPF patients in that study.



Position Overview:

We are seeking an innovative, scientific and collaborative regulatory expert to join our team as a Director, Regulatory Affairs to play a vital role in developing regulatory strategies that ensure successful completion of early phase and pivotal studies in support of the development and registration of rare respiratory disease programs. The incumbent will manage US FDA interactions and contribute to the content and preparation of global regulatory documents/submissions related to applicable programs. This position will report to the VP, Regulatory Affairs, and work closely with the cross-functional program teams in Avalyn.

Key Responsibilities:

• Develop and implement innovative regulatory strategies to support nonclinical, clinical, CMC and drug-device development in support of regulatory registration of the company’s products primarily in the US but also in support of other regions (EU, Canada, rest of world).
• Refine regulatory strategies and be accountable for conducting regulatory risk planning and mitigation as new data become available.
• Work as the primary contact with US regulatory agencies on a daily basis.
• Represent Regulatory Affairs on project teams to resolve complex project issues by providing regulatory expertise and interpretation of regulations to find the best development strategies for the products.
• Prepare and ensure compliance with IND/CTA reporting obligations including IND safety reports, DSURs, updates to investigator brochures for submission to health authorities.
• Author and collaborate on the preparation of major clinical submissions required for regulatory approval (authoring of portions of INDs/CTAs/device submissions, briefing book content, regulatory designation requests, orphan drug designations, pediatric plans). Ensure that they are fit for purpose.
• Execute on tactical and administrative operations including maintaining regulatory information management and tracking regulatory communications.
• Review critical documents such as clinical protocols, clinical study reports, preclinical study reports, and CMC documents to support submissions as needed.
• Participate in regulatory intelligence gathering activities and maintain knowledge of ICH requirements and regional requirements for international territories US, EU, and rest of world.
• Develop, communicate, and implement submission planning timelines and metrics and escalate any timeline issues to management.
• Assist in the coordinate with internal and external resources for on-time delivery of high-quality regulatory submissions to regulatory agencies.

The ideal candidate for this role will have:

• Minimum of Bachelor’s degree in a scientific discipline such as pharmacy, biology, chemistry, pharmacology, clinical medicine or related life science (required).
• A strong clinical foundation (required).
• 8 years’ experience in the biotech or pharmaceutical industry, medical device industry, or health authority with at least of 5 years’ experience in Regulatory Affairs (managing phase 1 through NDA) (required).
• A thorough knowledge and understanding of pharmaceutical development and regulatory requirements for product development and approval in the US (required).
• Drug-device combination experience is a plus
• Hands-on experience preparing and submitting INDs and managing international regulatory filings (e.g., CTAs).
• Demonstrated working knowledge of worldwide health authority laws, regulations, and guidances (including ICH) is necessary. Oversight of global health authority interactions is desired.
• Experience leading teams, setting clear direction, holding people accountable and fostering a collaborative team environment is required.
• Well-developed critical reasoning skills and risk management ability
• Demonstrated experience working independently and with multiple stakeholders in a team environment with ability to influence and negotiate for greater outcomes.
• Prior experience in respiratory therapeutic area with an understanding of competitors product developments is desired.
• The ability to effectively prioritize assignments for multiple products and projects simultaneously and be comfortable with both routine regulatory work as well as strategic and tactical elements in regulatory affairs is required.

This is a remote position.