• Lead the planning and preparation of standalone CMC submissions and response to health authority (HA) inquiries • Define submission strategies and content; identify regulatory approval risks and propose mitigation plans • Provide authoring support as needed • Review CMC components of relevant documents and contribute to content development as appropriate • Represent Regulatory CMC in cross-functional meetings and collaborate with internal and external stakeholders on assigned projects • Partner with Quality and other functions to assess the regulatory impact of proposed changes to clinical materials and commercial products • Stay current with international and domestic regulatory requirements and best practices • Provide guidance on interpreting and implementing regulations, guidelines, company procedures, and working practices

• Monitor & Analyze: Track global regulatory changes, guidance documents, and policy trends across key markets (FDA, EMA, PMDA, etc.) or stakeholders (EU Commission, ICH, ISO, etc.). • Impact Assessment: Liaise with relevant internal stakeholders and evaluate the implications of regulatory updates on the client's development programs and operational practices. • Stakeholder Alignment: Interact with Regulatory Affairs, Clinical, Quality, Pharmacovigilance and Legal teams to ensure alignment and awareness with key areas of interest and hot topics. • Communication: Contribute to the creation of and distribute internal newsletters, alerts, and briefing documents tailored to various audiences. • Publish relevant selected content to internal Engage forum. • Precedent Searches: Contribute to preparatory research and drafting of responses to precedent searches requests from various stakeholders. • Knowledge Management: Maintain a centralized repository of regulatory intelligence resources and ensure accessibility across teams. • External Engagement: Participate in industry forums, working groups, and regulatory intelligence networks to stay ahead of emerging trends.

• At Rho, we are not just a typical CRO; we inspire innovation in the life sciences. Join our dedicated team where curiosity fuels progress, collaboration is encouraged, and every day brings an opportunity to impact the world of clinical research. • Provide strategic and tactical leadership to Rho clients and project teams in support of our clients’ interdisciplinary pharmaceutical, biologic, and medical device development programs and regulatory submissions. • Serve as an integrated product development and regulatory expert at Rho, responsible for product development activities and services required to support the development programs and regulatory submissions of Rho’s clients, including gap analyses, strategic planning, development of integrated regulatory and clinical strategies and development plans, design of clinical studies, and authorship and review of study protocols, study reports, and regulatory submissions. • On behalf of Rho’s clients, lead integrated pharmaceutical, biologic, and medical device product development programs consisting of clinical, nonclinical, chemistry, manufacturing and controls, and regulatory components. • Provide leadership, guidance, and support to teams, programs, or projects of large scope, as well as to the Program Management discipline within the company. • Mentor and advise staff in areas of expertise by providing strategic and tactical guidance to team members, creating a strong sense of team unity and team identity, and providing regular and ongoing positive and corrective feedback to team members. • Proactively identify risks and critically analyze problems affecting the programs and develops contingency plans as needed. • Facilitate achievement of strategic goals for a program. • Monitor ongoing progress of key deliverables against Global Integrated Product Development Plan goals, including the identification of potential risks and contingency plans. • Ensure effective, accurate and timely communication of key issues and progress to project stakeholders and senior management. • Manage the strategic, regulatory authorship, biostatistical, and data submission components of regulatory submissions projects including INDs, IMPDs, IDEs, NDAs, BLAs, MAAs, and PMAs or portions thereof and is comfortable with all requirements related to electronic submissions. • Author Integrated Summaries of Safety, Integrated Summaries of Efficacy, and other complex regulatory documents. • Develop and review clinical study protocols, investigator’s brochures, clinical study reports, and other key clinical development documents. • Lead the planning, preparation, and conduct of regulatory authority meetings, and participates in discussions with regulatory authorities as appropriate. • Manage scope of work, budget, and timelines for external vendors, including consultants, external medical writers, nonclinical toxicology houses, and other vendors. • Moderate regulatory authority meetings. • Participate in business development activities, including assisting in the identification and assessment of new opportunities, representing Rho at conferences and meetings, and conducting capture activities for anticipated proposals; serve as a proposal leader for commercial proposals with specific responsibility for the development and articulation of the technical strategy sections of the proposal; provide guidance and input to the budgets and business submissions of proposals. • Mentor other technical leads in business development and proposal creation activities.

• Handle renewals, licensing items, and new license applications in current and future states • Maintain Hometap's existing suite of state mortgage licenses, including broker, lending, servicing, and collection agency licenses as applicable • Assist with license expansion efforts, including preparing and filing applications for new or additional licenses in NMLS and directly with states • Track and assist with individual MLO licensing, including pre-license education, examination scheduling, and annual continuing education • Oversee all NMLS matters related to licensing and registration for both the company and sponsored individuals • Assist with filing annual and periodic reports with NMLS and various Secretary of State offices • Implement change management items related to licensing • Create, maintain, and update licensing procedural manuals, job aids, and tools • Assist with preparing and filing the Mortgage Call Report and other required state filings • Support various ad-hoc licensing projects