Syner-G BioPharma Group is seeking a Regulatory Affairs Consultant to support a global pharmaceutical client in Chemistry, Manufacturing, and Controls (CMC), focusing on post-approval regulatory submissions, providing strategic regulatory guidance and operational support to ensure compliance with FDA, EMA, and global regulatory requirements.
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Executes the regulatory strategy for obtaining registration approval of Intuitive's portfolio, according to plan and coordinate with related cross functional teams to compile regulatory documentation for submission to regulatory authorities, maintenance of licenses and change management. Evaluates medical device changes, determines and executes regulatory strategy and ensures compliance. Leads advocacy effort across applicable product regulations, environment management regulations and standards related activities with relevant regulators and Government bodies.