Job Description
Senior CMC Regulatory Consultant (Small Molecules)nnInterim until end Sept 2026 – 6 month renewal ongoing.nnRemotennAre you a seasoned CMC Regulatory Affairs professional with expertise in small molecules? Are you ready to bring your knowledge and experience to a dynamic role where you can work remotely on impactful projects? If so, we have the perfect opportunity for you!nnWe are seeking a Senior CMC Regulatory Consultant specializing in small molecules.
This is a contract-based, remote position offering flexibility and the chance to make a significant impact in a thriving area of the regulatory landscape. You will join a team of experts, collaborating on intricate drug development and regulatory strategies, enabling compliance and smooth submissions in today’s highly regulated environment.nnKey Responsibilities:nn * Provide high-level expertise in CMC regulatory strategies for small molecule productsnn * Prepare, review, and deliver regulatory documentation to support product development, submissions, and lifecycle managementnn * Offer regulatory guidance to cross-functional project teams, ensuring compliance with global CMC guidelines and standardsnn * Troubleshoot and address complex regulatory challenges while maintaining timelines and qualitynn * Serve as a key contributor during regulatory agency interactions, offering insights and strategiesnnWhat We’re Looking Fornn * A strong background in Regulatory Affairs with a specific focus on Regs CMC and small molecules (10+ years specifically in small molecule regulatory CMC activities)nn * Proven experience in preparing and managing regulatory submissions aligned with global health authoritiesnn * An independent, proactive problem-solver with excellent communication and organizational skillsnn * Adept at navigating the complexities of remote collaboration with international teamsnnregulatory, CMC, small, molecule, RA, affairs, pharmaceutical, strategy, lifecycle
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