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 outcomesRequirements: • Bachelor's or advanced degree in a related field • 3+ years in CMC regulatory affairs • Familiarity with FDA and Health Canada regulatory processes • Experience with DMFs and drug submissions • High attention to detail and problem-solving skillsSupport ClinChoice's global initiatives and drive successful product development through your regulatory expertise. #J-18808-Ljbffr
Remote Cmc Regulatory Strategist At Clinchoice
CLINCHOICE INC.
winnipeg, winnipeg
Published 21 days ago
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