Senior Regulatory Affairs Associate

Job Summary

A company is looking for a Senior Associate Regulatory Affairs.

Key Responsibilities

• Support day-to-day operations and interactions with global regulatory authorities
• Compile and manage regulatory submissions in compliance with ICH, FDA, and company policies
• Assist in developing SOPs and regulatory strategies while staying updated on regulatory changes

Required Qualifications, Training, and Education

• Bachelor's degree in a relevant field
• Two or more years of experience in a Regulatory Affairs department at a drug or biologics company
• Familiarity with FDA regulations and ICH guidelines
• Technical expertise in Windows, MS Office, Adobe Acrobat, and electronic document management systems
• Experience in global clinical trials and oncology drug development is a plus