Local Regulatory Representative Lead

Job Overview

Welcome to CSL, where science meets purpose and every day brings a chance to help patients around the world. We are looking for a Regulatory Representative Lead to bring strategic, forward-thinking regulatory leadership to our APAC Region. In this role, you will guide affiliate and distributor regulatory management and shape regional regulatory strategies for new and existing CSL Behring products. Your work will span every developmental and commercial lifecycle phase across multiple markets.

Responsibilities

You will be part of a team of high-performing regulatory affairs professionals who work together in a productive, harmonized way to bring CSL Behring commercial plans to life in APAC. You will:

• Build and nurture this team, supporting each member to thrive.
• Collaborate closely with regional regulatory experts in the Therapeutic Areas across APAC markets.
• Design, deploy and maintain processes and systems that help distributors meet CSL, global and local regulatory compliance, including on-boarding, training and off-boarding.
• Provide strategic leadership, including risk-based oversight of regional programs. You will draw on stakeholder management and business planning knowledge to optimize implementation plans.
• Plan, lead and deliver complex regional strategies across a broad range of CSL Behring and CSL Vifor products and markets, keeping them aligned with company and commercial strategies.
• Take on other duties that may be assigned from time to time.

Requirements

• An advanced degree in natural or related life sciences (MS, PhD or MD, DVM).
• 7 – 10 years of relevant experience in the pharmaceutical industry; biologics regulatory experience preferred.
• Demonstrated experience of strategic leadership across product development and commercialisation lifecycle with examples of contribution.
• Demonstrated experience in building high performing RA teams and effective delivery of objectives in a complex matrix environment.