Senior Associate Regulatory Affairs

Job Summary

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