Senior Associate, Regulatory Affairs (US)

📋 Description

• • Plan, track, and execute U.S. regulatory submissions to the FDA for investigational and commercial products, including INDs, NDAs, and BLAs, as well as amendments and supplements.
• • Draft regulatory submission documents such as IND components and ensure all content aligns with FDA regulations and guidance.
• • Review regulatory documentation for accuracy, consistency, completeness, and compliance with eCTD technical specifications and FDA requirements.
• • Serve as the primary execution lead and cross-functional coordinator for assigned U.S. regulatory submissions, clarifying roles, timelines, and deliverables across teams.
• • Partner with U.S. Regulatory Strategists to translate high-level regulatory plans into actionable submission timelines and deliverable strategies.
• • Collaborate with Clinical, CMC, Safety, Nonclinical, Medical Writing, and Labeling teams to collect, organize, and finalize FDA submission-ready documents.
• • Perform Quality Control (QC) checks on regulatory dossiers to ensure compliance with FDA standards and eCTD formatting.
• • Liaise with Regulatory Publishing to support on-time, first-cycle-quality FDA submissions.
• • Maintain accurate, version-controlled archives of IND, NDA, and BLA submissions to ensure inspection readiness and document integrity.
• • Request FDA application numbers through the CDER NextGen Portal and track all FDA correspondence related to submissions.
• • Utilize regulatory tracking tools such as Veeva Vault RIM and submission trackers to monitor milestones, deliverables, and potential risks.
• • Monitor updates to FDA guidance and contribute to continuous improvement of U.S. regulatory submission processes.
• • Manage multiple U.S. regulatory submissions and competing priorities simultaneously under tight, FDA-driven deadlines.
• • Demonstrate strong organizational and documentation skills with a meticulous, detail-oriented approach to all regulatory activities.
• • Function as a trusted cross-functional partner in a matrixed regulatory environment with clear written and verbal communication skills.
• • Operate with a hands-on, execution-driven mindset and full accountability for deliverables and outcomes.
• • Work independently and collaboratively in a fast-paced, entrepreneurial environment with flexibility to adapt to evolving priorities.
• • Support regulatory affairs team and strategists in advancing strategies for the earliest possible approvals or clearance of regulatory submissions.
• • Apply sound judgment and practical business awareness in supporting regulatory execution decisions.
• • Demonstrate initiative, entrepreneurial mindset, and commitment to continuous learning in a dynamic regulatory landscape.
• • Exhibit results-oriented behavior and analytical thinking while maintaining compliance with FDA and ICH regulatory standards.