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Avalyn is a biopharmaceutical company developing inhaled therapies for the treatment of rare respiratory diseases including pulmonary fibrosis and other interstitial lung diseases (ILD). Pulmonary fibrosis is characterized by scarring of lung tissue, decline in lung function, reduced exercise capacity and quality of life, and is associated with increased mortality. Currently approved therapeutic options slow pulmonary fibrosis progression but are associated with significant toxicities that restrict their use and dosing. Avalyn is developing a pipeline of new inhaled formulations of approved medicines designed to reduce systemic exposure and deliver medication directly to the site of disease. Avalyn’s lead program, AP01, is an optimized inhaled formulation of pirfenidone, currently being studied in the ongoing MIST Phase 2b Study in progressive pulmonary fibrosis (PPF). Avalyn has initiated a Phase 1b study for its second program, AP02, inhaled nintedanib, that is being developed for the treatment of idiopathic pulmonary fibrosis (IPF). For more information, please visit avalynpharma.com and follow us on LinkedIn.

Position Overview:

As a Manager/Sr. Manager, Regulatory Affairs, you will play a pivotal role in providing operational support to Avalyn’s Global Regulatory Strategists and implementing regulatory strategy for development-stage drug-device combination products. As a member of the Regulatory Affairs organization, you will actively manage and prepare complex regulatory submission documents for global regulatory filings applying your comprehensive knowledge of US FDA regulations/guidelines and global ICH guidelines. Your organizational skills will be critical for executing on submission deliverables and for maintaining compliance with regulatory information management. In our small biotech environment, you’ll have the opportunity to directly influence key decisions, helping us achieve our mission of delivering life-changing therapies for patients with unmet needs. You will be reporting to the VP, Regulatory Affairs.

Key Responsibilities:

• Support Regulatory Affairs Strategists in contributing to innovative regulatory strategies to support nonclinical, clinical, CMC and drug-device development in support of regulatory registrations of the company’s products in target markets (US, Canada, Europe, Latin America, Asia-Pacific).
• Support Regulatory Affairs Strategists in resolving complex project issues by conducting regulatory intelligence research and reviewing and interpretating regulations and precedents. Assist in the critical analysis of the associated risks and issues.
• Maintain knowledge of US FDA and ICH requirements and regional requirements for international territories EU and rest of world.
• Collaborate with internal and external resources to ensure effective implementation of regulatory filing plans by managing timelines/metrics and identifying/reviewing the required documents for submission.
  • As US regulatory agent, you will have responsibility for US submission package preparation including required forms and cover letters.
  • In coordination with CROs, you will manage the preparation of clinical trial applications and submissions and routine CT maintenance outside of the US.
• Prepare and ensure compliance with IND/CTA/ODD reporting obligations including IND safety reports, annual reports/DSURs, updates to investigator brochures for submission to health authorities.
• Collaborate on the preparation of major clinical/regulatory documents 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.
• Review critical documents such as clinical protocols, clinical study reports, preclinical study reports, and CMC documents to support submissions as needed.
• Execute on tactical and administrative operations including maintaining regulatory information management and tracking regulatory communications. Take personal responsibility for the notification of regulatory activities and related database entry/data accuracy for allocated projects.
• Ensure archiving of activities, especially submissions, internal memos and key correspondence.
• Be responsible for communication of submission and approvals to relevant cross functional teams. Provide status updates to management.
• Ensure roles and responsibilities for external services within a project are clearly defined and documented. Proactively resolve issues related to outsourced activities.

Key requirements for this role are:

• Bachelor’s degree in a life sciences such as pharmacy, biology, chemistry, pharmacology, or a related field. A strong clinical foundation (required).
• 5-7 years of experience in the biotech, pharmaceutical, medical device industry, or with a health authority, with at least of 3 years’ experience in Regulatory Affairs (managing phase 1 through 3) (required). Preferred in publicly traded life science and/or biotech companies.
• 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, submitting and maintaining INDs and managing international regulatory filings (e.g., CTAs). NDA submission experience is a plus.
• Strong understanding of clinical trials, drug development, and regulatory requirements, with a focus on patient-centered drug development.
  • In depth knowledge of U.S. regulatory legislation and guidelines.
  • Demonstrated working knowledge of ICH guidelines is necessary.
• Ability to collaborate and lead in a cross-functional team with internal stakeholders including clinical development, clinical operations, project management, statistics, data management.
• Strong oral and written communication skills and interpersonal skills.
• Proven experience working with rare diseases or respiratory conditions is a plus.
• Strong organizational and time-management skills, working independently with the ability to prioritize and manage multiple projects simultaneously in a fast-paced environment with a drive for results and sense of urgency