@regulation

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Likes: Econ and public policy, slow cooked BBQ, and Canada ��. Loves: Optimism and empathy. Views are my own until I disown them.

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Regulatory Affairs Specialist / Study Startup EU Germany Czechia Spain Switzerland. Passionate regulatory affairs specialist driving clinical trial authorizations across Europe. EU CTR, MDR, CTIS, EMA, GCP. · Experienced clinical research professional with comprehensive expertise in study startup and regulatory affairs, dedicated to accelerating the initiation of clinical trials while ensuring full regulatory compliance across all stages. Proficient in managing the complete study startup lifecycle, including site identification and feasibility assessments, investigator selection, CTIS/ethics committee (IRB) submissions, informed consent development, essential document collection and review, and contract and budget negotiations with clinical sites and vendors. In-depth knowledge of the regulatory landscape at both national and international levels. Experienced in preparing, submitting, and managing regulatory filings with key authorities including the BfArM (Federal Institute for Drugs and Medical Devices), PEI (Paul-Ehrlich-Institut), EMA (European Medicines Agency), FDA (U.S. Food and Drug Administration), and national competent authorities across Europe and beyond. Skilled in the preparation of IND, CTA, NDA, MAA submissions, as well as clinical trial notifications, safety reporting, and post-approval modifications/amendments. Thorough understanding of GCP guidelines, EU Clinical Trials Regulation (EU CTR 536/2014), the EU Clinical Trials Information System (CTIS), and relevant national regulations governing the conduct of clinical trials. Adept at coordinating with ethics committees, regulatory bodies, and institutional review boards to secure timely approvals and maintain ongoing compliance. Brings strong cross-functional collaboration skills, working closely with sponsors, CROs, medical monitors, data management teams, pharmacovigilance departments, and legal teams to align operational and regulatory strategies. Experienced in developing and maintaining regulatory intelligence, monitoring evolving guidelines, and proactively adapting processes to meet new requirements. Committed to driving efficiency in study startup by implementing standardized workflows, leveraging technology platforms such as eTMF and CTMS systems, and applying risk-based approaches to identify and resolve potential bottlenecks early. Proven ability to manage multiple studies simultaneously across various therapeutic areas (inc. oncology, immunology, rare diseases, vaccines, and advanced therapy medicinal products) within complex, multi-country regulatory environments. A strategic partner who bridges the gap between regulatory science and clinical operations, ensuring that trials move from planning to first patient enrollment as quickly, compliantly, and efficiently as possible.

regulation

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