Job Description
**General Description:**
The Senior Associate plans, tracks, and executes U.S. regulatory submissions to the FDA for investigational and commercial products. The position supports IND, NDA, and BLA filings and serves as a key operational liaison between U.S. Regulatory Strategy, Regulatory Publishing, and cross‑functional stakeholders to ensure submissions are delivered accurately, on time, and in compliance with FDA requirements.
The role assumes end‑to‑end execution responsibility for assigned U.S. submissions and requires strong communication skills, exceptional organizational discipline, and a proactive, hands‑on mindset, as well as the ability to operate as a flexible, collaborative team player who is open to learning and adapting in a fast‑paced, deadline‑driven environment.
This role requires prior Regulatory Affairs experience, including hands‑on support of U.S. IND preparation and working knowledge of NDA submissions and related amendments or supplem...
The Senior Associate plans, tracks, and executes U.S. regulatory submissions to the FDA for investigational and commercial products. The position supports IND, NDA, and BLA filings and serves as a key operational liaison between U.S. Regulatory Strategy, Regulatory Publishing, and cross‑functional stakeholders to ensure submissions are delivered accurately, on time, and in compliance with FDA requirements.
The role assumes end‑to‑end execution responsibility for assigned U.S. submissions and requires strong communication skills, exceptional organizational discipline, and a proactive, hands‑on mindset, as well as the ability to operate as a flexible, collaborative team player who is open to learning and adapting in a fast‑paced, deadline‑driven environment.
This role requires prior Regulatory Affairs experience, including hands‑on support of U.S. IND preparation and working knowledge of NDA submissions and related amendments or supplem...