Job Description

Responsibilities

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- 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.
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- Support development of consistent roles and work processes.
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- Oversee development of plans, cost estimates, and schedules. Acquire the necessary permits and approvals.
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- Monitor regulatory developments and advise management on the potential impact of regulations on the organization.
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- Establish and maintain positive relationships with government agencies and other regulatory authorities.
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- Represent the organization in matters before regulatory, legislative, or industry standards agencies so the organization's interests are advanced.
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- Prepare materials for legal counsel or external consultants.
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- Create and compile of registration application documentation.
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- Regulatory system, data entry and maintenance in/of regulatory systems.
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Qualifications

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- Bachelor degree in a Life Science or Business Advanced degree in a Life Science (PhD, MD) or Business (MBA) an advantage.
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- 3+ years regulatory experience in the pharmaceutical industry. Biologics Regulatory experience preferred.
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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 Research Development & Sciences Global & Regional Regulatory Affai (Victoria)
🏢 CSL Vifor
📍 Victoria