Regulatory Affairs Manager

A company is looking for a Regulatory Affairs Manager to facilitate product development and global registration.Key Responsibilities• Assist in regional regulatory activities, including IMPD development and submission• Create and maintain product regulatory history documents and archive regulatory communications• Ensure compliance with regulatory submissions and coordinate quality control of documentationRequired Qualifications• Mixed background in laboratory, manufacturing, and process development• Experience in regulatory strategies for product manufacturing and quality programs• Ability to support regulatory agency interactions throughout the product lifecycle• Experience with regulatory documentation and agency communication• Ability to work flexible hours to support PST time zone