Responsibilities:• Plan, direct, and monitor regulatory affairs activities so the organization has the permits, licenses, certificates, authorizations, and other approvals needed to conduct current and future business activities; and produce, sell, and distribute its goods and services.
• Support development of consistent roles and work processes.
• Oversee development of plans, cost estimates, and schedules.
Acquire the necessary permits and approvals.
• Monitor regulatory developments and advise management on the potential impact of regulations on the organization.
• Establish and maintain positive relationships with government agencies and other regulatory authorities.
• Represent the organization in matters before regulatory, legislative, or industry standards agencies so the organization's interests are advanced.




• Prepare materials for legal counsel or external consultants.
• Create and compile of registration application documentation.
• Regulatory system, data entry and maintenance in/of regulatory systems.Qualifications:• Bachelor degree in a Life Science or Business Advanced degree in a Life Science (PhD, MD) or Business (MBA) an advantage.
• 3+ years regulatory experience in the pharmaceutical industry.
Biologics Regulatory experience preferred.Different qualifications or responsibilities may apply based on local legal and/or educational requirements.
Refer to local job documentation where applicable.

📌 Global Regulatory Affairs Manager (Victoria)
🏢 Csl Behring
📍 Victoria