Oncology Regulatory Affairs Director

A company is looking for an Associate Director, Regulatory Affairs (Oncology).

Key Responsibilities

Manage regional regulatory activities as part of a Global Regulatory Team

Lead regulatory activities for assigned projects in alignment with global registration strategy

Plan, coordinate, and prepare regulatory submissions while ensuring compliance with global regulatory requirements

Required Qualifications

Bachelor's degree in a related field, preferably in a scientific discipline

At least 7 years of experience in the biopharmaceutical or pharmaceutical industry, with a minimum of 4 years in regulatory affairs

Oncology product development experience preferred

Experience with electronic regulatory submissions and regulatory templates

Understanding of EU Clinical Trial Regulation and ROW country regulatory requirements related to clinical trials