Elevate your career as a remote CMC Regulatory Strategist with ClinChoice, supporting regulatory strategies and submissions across the product lifecycle. Utilize your specialized CMC expertise to make an impact.
This role involves a blend of strategy development and hands-on regulatory submissions for U.S. FDA and Health Canada. You will ensure high standards of compliance while partnering with CMC, Quality, and Manufacturing teams on various projects. This is a 12-month contract position, renewable based on performance.
Key Responsibilities:
• Develop regulatory strategies for product development
• Prepare CMC documents for regulatory filings
• Manage submissions and respond to Information Requests
• Oversee documentation for post-approval activities
• Collaborate with cross-functional teams to influence outcomes
Requirements:
• Bachelor's or advanced degree in a related field
• 3+ years in CMC regulatory affairs
• Familiarity with FDA and Health Canad...