Senior Regulatory Affairs Specialist

To facilitate product development and global registration, the full-time remote Senior Associate Regulatory Affairs will manage regulatory strategies and interactions for product manufacturing and quality programs throughout the product lifecycle. Key responsibilities: Contribute as a member of the global regulatory CMC product team Interact with authors and subject matter experts to deliver regulatory documents for submissions Document and archive CMC submissions and maintain product timelines Required qualifications: Master's degree, or Bachelor's degree with 2 years of relevant experience, or Associate's degree with 6 years of relevant experience, or High school diploma/GED with 8 years of relevant experience Experience in manufacture, process development, quality assurance, or quality control Regulatory CMC specific knowledge and experience Developed project management and organizational skills Strong oral and written communication skills