Associate Director, Regulatory Affairs

Job Summary

A company is looking for an Associate Director, Regulatory Affairs CMC.

Key Responsibilities

• Collaborate with functional leaders to create and negotiate optimal development paths for product candidates
• Execute CMC Submission and Authoring strategy in collaboration with the RA CMC Product Lead
• Ensure submission documents meet quality standards and adhere to corporate and regulatory guidelines

Required Qualifications, Training, and Education

• Minimum of a BA/BS in Life Science
• 5-8 years of experience in pharmaceutical/biotechnology related to regulatory affairs
• Expertise in writing CMC content for regulatory submissions, particularly for Biologic and Cell Therapy Products
• Understanding of biological lifecycle drug development and familiarity with ICH and CTD guidelines
• Experience with project management and compliance with GDP, GCP, and GMP standards