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.

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📌 Global Regulatory Affairs Manager Research Development & Sciences Global & Regional Regulatory Affairs CSL Behring Melbourne, Victoria, Australia8 Posted on September 4, 2026
🏢 CSL Vifor
📍 Melbourne