Job Description
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 Canada regu...
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 Canada regu...