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Head of Regulatory Affairs at best of human GmbH

victoria, Victoria, Australia -

Full Time

Start Date

Immediate

Expiry Date

11 Jan, 27

Salary

54000.0

Posted On

13 Oct, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Industry

Pharmaceutical Manufacturing

Description

Contributes to the development, maintenance, and implementation of global regulatory strategies for assigned products, projects, submissions, or lifecycle activities under the direction of senior regulatory leadership
Supports strategic and operational regulatory planning across development, registration, and post-authorisation phases, including identification of regulatory risks, options, assumptions, and mitigation approaches
Supports preparation, critical review, coordination, and submission of regulatory documents, including clinical trial applications, marketing authorisation applications, amendments, variations, supplements, responses to health authority questions, and lifecycle submissions
Provides regulatory input to cross-functional teams to support compliant development plans, clinical trial designs, submission documents, labelling considerations, and lifecycle activities
Supports health authority interactions by coordinating input, preparing briefing materials, drafting responses, contributing to meeting strategy, and participating in meetings as required
Reviews regulatory documents and project deliverables for quality, consistency, scientific accuracy, completeness, and alignment with agreed regulatory objectives

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Responsibilities