Remote Regulatory Strategy Lead – Australia

Parexel

Australia

Remote

AUD 140,000 - 190,000

Full time

2 days ago

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Job summary

Parexel is seeking an experienced Regulatory Affairs professional in Australia to own and develop regulatory strategy across major programs. You will provide leadership on authority engagement, submission planning, and risk mitigation, coordinating cross-functional teams to ensure compliance and timely submissions.

The role requires strong expertise in MAAs, CTD/eCTD, and Module 1 content, with the ability to lead multiple priorities in a fast-paced environment.

Qualifications

Significant Regulatory Affairs experience in Australian product development and lifecycle management.
Proven experience leading or supporting health authority interactions.
Strong understanding of MAAs and CTD/eCTD dossier requirements.
Experience preparing and reviewing regulatory documentation, including Module 1 content.

Responsibilities

Develop and implement regulatory strategy across programs to align with business goals.
Lead major regulatory decisions including authority engagement models and risk mitigation.
Plan and execute high-impact regulatory submissions with cross-functional teams.
Collaborate with clinical, scientific, and commercial teams to align strategy with development timelines.
Monitor regulatory landscape changes and advise on submission approaches.