Regulatory Affairs Senior Manager

Job Summary

A biotech company is looking for a Regulatory Affairs Senior Manager.

Key Responsibilities:

• Coordinate CMC Regulatory submissions, including CTAs/INDs, CMAs/BLAs and post-approval variations/supplements
• Communicate and coordinate with relevant functional groups and project team members
• Liaise with in-country regulatory leads for global submissions and manage completion of source documents

Required Qualifications:

• Bachelor's degree in a scientific field, preferably with an advanced degree
• 6-10 years of experience in the biotechnology industry, with 4-5 years in Regulatory Affairs CMC
• Background in vaccine development and knowledge of the vaccine development process
• Experience with global regulatory submissions and current Good Manufacturing Practices and ICH guidelines
• Experience with CTD format and content, and familiarity with electronic document management systems