Senior Associate, Regulatory Affairs

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

📋 Description

• Oversee the preparation and implementation of U.S. regulatory submissions (INDs, NDAs, BLAs, amendments, supplements) in accordance with FDA regulations and guidelines.

• Create regulatory submission documents (e.g., components of IND) as necessary.

• Evaluate regulatory documentation to ensure precision, consistency, and completeness, supporting the efficient execution of submissions to health authorities.

• Act as the main execution lead and cross-functional coordinator for designated U.S. regulatory submissions, ensuring clear roles, timelines, and deliverables.

• Collaborate with U.S. Regulatory Strategists to convert regulatory strategies into actionable submission timelines and deliverable plans.

• Work alongside Clinical, CMC, Safety, Nonclinical, Medical Writing, and Labeling teams to gather and organize documents ready for FDA submission.

• Conduct Quality Control (QC) checks to guarantee accuracy, consistency, and adherence to eCTD technical specifications and FDA requirements.

• Coordinate with Regulatory Publishing to facilitate timely, high-quality submissions to the FDA on the first cycle.

⛳️ Requirements

• A BA/BS degree, ideally in a scientific or health-related field OR over 3 years of experience in Regulatory Affairs, including direct support of U.S. IND preparation is required.

• Proficiency with CTD/eCTD formats.

• Experience in publishing documents using Adobe Acrobat Professional.

• Familiarity with the FDA's structure and a working knowledge of FDA and ICH regulatory guidelines and regulations is preferred.

• Capability to manage multiple U.S. submissions and priorities concurrently.

• Excellent organizational and documentation skills.

• Aptitude for working both independently and collaboratively under stringent FDA-driven timelines.

🏝️ Benefits

• Medical

• Dental

• Vision

• 401(k)

• FSA/HSA

• Life Insurance

• Paid Time Off

• Wellness

• Employee Stock Purchase Plan

• Discretionary equity awards