Avalyn Pharma

Compliance

• Support the development and execution of global regulatory strategies across nonclinical, clinical, CMC, and device components for Avalyn's development programs.
• Translate regulatory strategy into actionable plans, timelines, and deliverables.
• Identify regulatory risks and support development of mitigation strategies in partnership with senior regulatory leadership.
• Provide regulatory support across multiple development programs and portfolio initiatives.
• Coordinate preparation, review, and submission of regulatory filings, including INDs, CTAs, amendments, annual reports, orphan drug applications, briefing packages, and other global submissions.
• Author and/or contribute to key regulatory documents and submission content.
• Support Phase 3 and marketing application readiness activities.
• Support regulatory meetings and interactions with FDA and other global health authorities, including preparation of responses and follow-up activities.
• Ensure submissions and regulatory communications are high quality, compliant, and delivered on time.
• Maintain regulatory tracking systems, dashboards, and tools used to manage submissions, commitments, correspondence, and key milestones.
• Support organization and maintenance of Regulatory Affairs documentation within SharePoint and other document management systems.
• Manage regulatory operational activities, including submission tracking, document management, compliance reporting, and archiving.
• Monitor evolving regulatory requirements and contribute to process improvements, standards, and best practices that support compliance and operational excellence.
• May serve as regulatory lead for selected routine agency interactions under senior oversight.
• Work closely with Clinical Development, Clinical Operations, CMC, Nonclinical, Quality, and Program Management teams to ensure regulatory considerations are integrated into program plans.
• Participate in cross-functional project teams as the regulatory representative for assigned programs and development activities.
• Contribute to a collaborative and high-performing regulatory environment and provide guidance to junior team members as appropriate.
• Build increasing responsibility for assigned development programs over time under the guidance of senior regulatory leadership.

Explore Senior Manager, Regulatory Affairs at Avalyn Pharma. Review requirements and application details.