CMC Regulatory Affairs Manager - FSP client dedicated

include developing and implementing regulatory strategies, authoring / reviewing of quality submission packages, ensuring their accuracy and timely delivery, and coordinating responses to health authorities for the company’s large molecule therapeutic drug candidates throughout their clinical development towards marketing approval as well as global life cycle management projects. Additionally, the job requires strong communication and coordination with external partners, contributing to risk assessments and mitigation strategies. In this role you will have a front seat in the heart of a development/commercial organization and able to weigh into CMC development strategies.

Demonstrates strong leadership, effective cross-functional collaboration, and excellent communication skills.

ROLES AND RESPONSIBILITIES

Develop, plan and execute appropriate regulatory strategies of pre-clinical, clinical (early to late stage), and commercial stage programs in close collabora...