Job Title

We are seeking an experienced Senior Manager, Regulatory Affairs to support global regulatory activities and key submission deliverables for our growing biotech organization. This role is well-suited for someone who is hands-on, highly organized, and comfortable working in a lean, fast-paced environment. Requirements 5 years of Regulatory Affairs experience within biotech or pharma. Experience preparing and supporting U.S. submissions (INDs, amendments, meeting packages). Strong project management skills with the ability to drive timelines and deliverables. Ability to work independently and effectively within a small, dynamic biotech environment. Excellent communication, organizational skills, and strong attention to detail. Biological logic development Key Responsibilities Support global regulatory strategy and execution for U.S. and ex-U.S. programs. Lead and coordinate IND/CTA submissions, protocol amendments, and responses to health authority queries. Manage submission timelines, tracking tools, and cross-functional project coordination. Collaborate closely with Clinical, CMC, Nonclinical, and external vendors to ensure high-quality regulatory deliverables. Assist with document authoring, QC review, and submission-readiness activities. Knowledge of U.S. regulatory submissions and eCTD format is strongly preferred