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.
, , canada, , , canada
Published 21 days ago
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