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Lead CMC review of technical documentation for regulatory filings in US and EU markets, including Gap Analysis and Remediation for Module 3 (CMC).
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Develop and implement regulatory strategies, processes, and timelines for new product registrations, variations, renewals, and post-approval changes in the US and EU.
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Oversee the preparation, review, and submission of CTD dossiers, ensuring conformance with FDA, EMA, and ICH guidelines.
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Critically evaluate submission documentation for scientific accuracy, compliance, and internal consistency.
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Provide regulatory intelligence by tracking changes in US and EU regulations, guidelines, and best practices.
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Collaborate closely with cross-functional teams (R&D, QA, Manufacturing, and Commercial) to ensure regulatory strategies are aligned with business objectives.
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Represent the company in discussions with regulatory authorities (FDA, EMA, and other relevant agencies).
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In-depth knowledge of US FDA, EMA, and ICH CMC guidelines.
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Strong ability to interpret and analyze complex technical and scientific data.
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Exceptional oral and written communication skills, with strong presentation abilities.
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Proven leadership and mentoring skills with a collaborative, results-driven style.
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Excellent problem-solving and decision-making capabilities.
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Proficiency with document management systems and Microsoft Office Suite (Word, PowerPoint, Excel, Outlook).
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Ability to manage multiple priorities and deliver high-quality outputs under pressure.