Associate Director, Regulatory Submissions

Medpace; Melbourne; On-site; AUD 120,000 - 160,000; Full time

Benefits offered by this job

Flexible work environment

Competitive compensation and benefits package

Structured career paths with opportunities for professional growth

Company-sponsored employee appreciation events

Employee health and wellness initiatives

Job summary

A leading clinical research organization is seeking an Associate Director, Regulatory Submissions in Melbourne, Australia. This role involves managing a global Study Start-up team, driving strategic development, and fostering client relationships. The ideal candidate will have over 10 years of leadership experience in a CRO or pharmaceutical context, demonstrating strong presentation and negotiation skills. This position also offers hybrid working arrangements, competitive compensation, and benefits aimed at fostering professional growth within the organization.

Qualifications

• 10+ years of leadership experience in Study Start-up within a CRO or pharmaceutical company.
• Strong written and oral communication skills.
• Regional experience is a plus.

Responsibilities

• Contribute to the growth and strategic development of a global Study Start-up team.
• Oversee Study Start-up/Regulatory Submissions activities and timelines.
• Develop relationships with clients and support the local Australian team.

Skills

Excellent presentation skills

Negotiation skills

Leadership skills

Interpersonal skills

Strong customer focus

Adaptability in stressful situations

Education

Bachelor’s degree in life sciences or related field

Advanced degree preferred

Job description

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.