This person will act as a senior scientific and regulatory advisor to HMNC, helping the team decide what data are sufficient, what additional studies are truly needed, how to justify dose and study design decisions, and how to communicate these decisions credibly to authorities such as BfArM, EMA, FDA, and other national competent authorities. • Prepare, review, and challenge key development and regulatory documents, including protocols, study reports, investigator brochures, briefing packages, IND/CTA/IMPD documents, CTD sections, authority responses, and scientific position papers. • Support preparation for and participation in interactions with BfArM, EMA, FDA, and other relevant authorities, including development of clear scientific arguments and response strategies. • Demonstrated experience preparing, reviewing, and defending regulatory and development documentation, including protocols, ...
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