Author, review, and lead high-quality clinical and regulatory documents (CTD), including clinical overviews and clinical summaries, clinical expert statements, Risk Management Plans (RMPs), SmPCs, CCDS, PILs, PSURs / DSURs, and other lifecycle management documents - We are looking for a hands-on Medical Expert responsible for driving clinical, scientific, and regulatory activities across the product lifecycle, with a strong focus on the development of high-quality regulatory documentation, scientific data interpretation, and support for global submissions and lifecycle management. You will support regulatory interactions, benefit-risk assessments, and evidence-based decision-making in collaboration with clinical development, regulatory affairs, pharmacovigilance, and other key stakeholders. In this ro
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