Advise on regulatory strategy, program priorities, and regulatory pathways across the• company's development portfolio Work closely with the clinical development consultant and internal teams to align regulatory• strategy with clinical development plans, trial design, and program timelines Lead planning and preparation of IND submissions, including authoring, review, and• coordination of nonclinical, clinical, and CMC (Module 3) sections Plan and prepare for interactions with regulatory agencies, including pre-IND, INTERACT,• and other formal meetings, as well as briefing documents and meeting requests Participate in meetings with company leadership, regulatory authorities, clinical• investigators, and external development partners, as requested Review and provide strategic regulatory input on scientific data, study reports, protocols,• investigator brochures, and other development materials Advise on applicable regulatory requirements and guidance, including GLP, GCP, GMP, and• FDA/ICH guidelines relevant to biologic therapeutics Identify regulatory risks and opportunities, including expedited development programs (e.g.,• Fast Track, Breakthrough Therapy, Orphan Drug designation), and recommend mitigation or• pursuit strategies Advise on the selection, oversight, and engagement of regulatory vendors, publishing• partners, and CROs supporting regulatory activities Support maintenance of regulatory filings after IND submission, including amendments,• safety reporting requirements, and annual reports Provide additional strategic regulatory advice and subject-matter expertise as reasonably• requested by the company Work closely with scientists and operators in a fast-paced biotech startup environment,• operating effectively with a high degree of autonomy. This person will work• closely with company leadership, internal teams, and the company's clinical development• consultant to make sure clinical and regulatory strategies are aligned.