Senior Regulatory Affairs Consultant / Regulatory Project Lead, Auckland

Job Title: Senior Regulatory Affairs Consultant / Regulatory Project Lead If you are passionate about innovative therapies, love leading complex regulatory filings, and prioritize quality, on-time, and within-budget project deliverables, Parexel is expanding and currently has openings for senior regulatory professionals. These are excellent opportunities to join a close-knit team of experienced colleagues.As a Senior Regulatory Affairs Consultant / Regulatory Project Lead, you will provide leadership to experienced project teams, managing the daily operations and complexities involved in preparing and filing NDA and/or BLA applications. Your goal will be to achieve operational excellence through timely delivery that meets budget and quality standards, exceeding client expectations.Qualifications: Minimum undergraduate degree in a clinical or health-related field; advanced degree preferred. At least 10-15+ years of experience leading US FDA filings within a CRO, biotech, or pharmaceutical company; previous CRO or consulting experience is highly preferred. Experience overseeing cross-functional teams involved in creating US regulatory filings, including NDAs and/or BLAs.Vaccine experience is a plus. Skills in project scheduling, resource and budget management, and team coordination. Regulatory affairs experience. Ability to build and sustain relationships, think critically, influence teams, and manage finances. Strategic thinking, attention to detail, conflict management, consulting, contingency planning, and people management skills.Excellent communication skills, client-focused attitude, flexibility, and ability to manage multiple tasks. Fluent in English and Korean (oral and written) is highly preferred. Proficiency in Microsoft Excel, PowerPoint, MS Project, and Word; experience with Parexel systems is a plus. Willingness to work in a matrix environment and value teamwork.Experience managing project budgets and financials. Up to approximately 20% domestic and/or international travel may be required. Employment is contingent upon disclosure of COVID-19 vaccination status and proof of vaccination if applicable. #J-18808-Ljbffr