Senior Manager, Regulatory Affairs

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in the formulation and implementation of global regulatory strategies encompassing nonclinical, clinical, CMC, and device elements for Avalyn's development initiatives.

• Convert regulatory strategies into practical action plans, timelines, and deliverables.

• Recognize regulatory risks and aid in developing mitigation strategies in collaboration with senior regulatory leadership.

• Offer regulatory support across various development programs and portfolio projects.

• Oversee the preparation, review, and submission of regulatory filings, including INDs, CTAs, amendments, annual reports, orphan drug applications, briefing packages, and other global submissions.

• Draft and/or contribute to essential regulatory documents and submission content.

• Assist with Phase 3 and marketing application readiness activities.

• Support regulatory meetings and interactions with the FDA and other global health authorities, including preparing responses and follow-up actions.

• Ensure submissions and regulatory communications are of high quality, compliant, and submitted punctually.

• Maintain regulatory tracking systems, dashboards, and tools for managing submissions, commitments, correspondence, and key milestones.

• Aid in the organization and upkeep of Regulatory Affairs documentation within SharePoint and other document management systems.

• Oversee regulatory operational tasks, including submission tracking, document management, compliance reporting, and archiving.

• Keep abreast of changing regulatory requirements and contribute to enhancements, standards, and best practices that foster compliance and operational excellence.

• May act as the regulatory lead for certain routine agency interactions under senior oversight.

• Collaborate closely with Clinical Development, Clinical Operations, CMC, Nonclinical, Quality, and Program Management teams to ensure regulatory aspects are integrated into program plans.

• Participate in cross-functional project teams as the regulatory representative for assigned programs and development efforts.

• Foster a collaborative and high-performing regulatory environment, providing guidance to junior team members when necessary.

• Gradually take on more responsibility for assigned development programs over time under the direction of senior regulatory leadership.

⛳️ Requirements

• A minimum of a Bachelor’s degree is mandatory; an Advanced degree (e.g., MS, PharmD, PhD, etc.) or regulatory affairs training/certification is preferred.

• At least 5-8 years of regulatory affairs experience within the pharmaceutical, biotechnology, or combination product sectors, with operational support for global clinical trials and direct authorship of regulatory submissions for investigational and commercial products.

• Experience in supporting global development programs across one or more phases of clinical development, with hands-on preparation and maintenance of regulatory submissions (e.g., INDs, CTAs, amendments, annual reports, and health authority meeting materials).

• Familiarity with drug-device combination products and their specific regulatory considerations is advantageous.

• Strong knowledge of U.S. FDA regulations, ICH guidelines, and eCTD submission requirements; experience with orphan drug, expedited, or other special regulatory pathways is a plus.

• Proven experience in facilitating regulatory interactions with the FDA and/or other global health authorities.

• Demonstrated ability to effectively collaborate within cross-functional teams, including Clinical Development, Clinical Operations, CMC, Nonclinical, Quality, and Program Management.

• Excellent project management, organizational, and communication skills, with a proven ability to manage multiple priorities and deadlines in a dynamic environment.

• Experience with regulatory information management systems, document management platforms, and/or SharePoint is preferred.

• Experience in a small biotechnology company or matrixed environment is desirable.

🏝️ Benefits

• Competitive salary and bonus structure.

• Comprehensive health, dental, and vision insurance.

• Retirement savings plan with company match.

• Generous paid time off and holiday schedule.

• Opportunities for professional development and career growth.