Remote Dir Regulatory Affairs CMC Consultant (Austell, GA)

Remote Dir Regulatory Affairs CMC Consultant

jobs(at)globalchannelmanagement.coms www.globalchannelmanagement.com jobopenings Remote Dir Regulatory Affairs CMC Consultant needs 8 years of experience in Regulatory Affairs related to development of pharmaceuticals with a minimum of 6 years in Chemistry Manufacturing and Control (CMC) regulatory environment Oncology experience preferred. Remote Dir Regulatory Affairs CMC Consultant requires Bachelor of Science in a scientific discipline (Chemistry Biochemistry or related pharmaceutical science) advanced degree Small molecule and biologics knowledge is preferred. Bachelor of Science in a scientific discipline (Chemistry Biochemistry or related pharmaceutical science) advanced degree preferred. Established working knowledge of regulatory guidelines and regulations (US and international). Regulatory experience supporting both development projects and marketed products. Strong knowledge of eCTD elements and structure and regulatory writing skills. Prior experience with NDA BLA submission is strongly preferred.Remote Dir Regulatory Affairs CMC Consultant duties Provides strategic guidance on FDA and global CMC regulatory requirements for investigational and commercial products. Compiles reviews and approves CMC modules of development and marketing registration applications amendments and supplements for submission. Develops and implements CMC regulatory strategies for the earliest possible product approval. Assists with preparation and lead meetings with Health Authorities. Manages and ensures compliance with all reporting requirements including annual and periodic reports. Serves as CMC regulatory lead at internal meetings as well as at meetings with business partners and regulatory agencies for all CMC related issues. Assesses and communicates CMC regulatory requirements to ensure all development activities are following applicable regulations and guidelines. Leads and assists in preparation of Policies Standard Operating Procedures and Work Instructions Mentors and develops regulatory talent within the regulatory department Other duties as assigned.