Associate Director, Regulatory Submissions Join to apply for the Associate Director, Regulatory Submissions role at Medpace We are seeking a key manager to support the Medpace Study Start‑up group in the APAC Region while being office‑based in Melbourne, Australia. This position will be an integral part of the Medpace clinical operations management team, responsible for the strategic development of the group and continuous improvement of processes. As a leader of the Study Start‑up team, you will provide input on new business development opportunities, develop and maintain client relationships, and guide the Regulatory Submissions team on competent authority and all applicable submissions. Additional or alternative expertise in other facets of Study Start‑up is welcomed. Responsibilities Contribute directly to the growth and strategic development of a large, global Study Start‑up team. Develop and identify continuous improvement opportunities in internal processes. Project lead: oversee Study Start‑up/Regulatory Submissions activities and timelines, ensuring compliance with Medpace SOPs and study protocols. Provide input on new business development opportunities. Develop and maintain relationships with clients. Support the local Australian team development. Qualifications Bachelor’s degree in life sciences or a related field; advanced degree preferred. +10 years of Study Start‑up leadership experience within a CRO or pharmaceutical company. Excellent presentation, negotiation, documentation, leadership, team‑orientation, and interpersonal skills. Strong customer focus with the ability to manage challenging priorities and remain flexible and adaptive in stressful situations. Excellent written and oral communication skills. Regional experience. Hybrid working arrangements may be offered. Medpace Overview Medpace is a full‑service clinical contract research organization (CRO). We provide Phase I‑IV clinical development services to the biotechnology, pharmaceutical and medical‑device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through a scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti‑viral and anti‑infective areas. Headquartered in Cincinnati, Ohio, Medpace employs more than 5,000 people across 40+ countries. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company‑sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America’s Most Successful Midsize Companies in 2021, 2022, 2023, and 2024. Continually recognized with CRO Leadership Awards from Life Science Leader magazine. What To Expect Next A Medpace team member will review your qualifications and, if interested, contact you with details for next steps. #J-18808-Ljbffr