Strategic Regulatory Affairs Lead (Australia) Remote

Parexel; Australia; Remote; AUD 120,000 - 170,000; Full time

Job summary

Parexel in Australia seeks a senior Regulatory Affairs professional to own and develop regulatory strategies across major programs, ensuring alignment with business objectives and regulatory requirements.

You will lead authority engagement, manage submissions planning, lifecycle management, and collaborate with clinical, scientific and commercial teams to align regulatory activities with development timelines and market opportunities.

Qualifications

• Significant Regulatory Affairs experience in Australian product development and lifecycle management.
• Proven experience leading or supporting health authority interactions and regulatory procedures.
• Strong understanding of MAAs and CTD/eCTD dossier requirements.
• Experience preparing and reviewing regulatory documentation including Module 1 and briefing materials.
• Expertise in regulatory strategy development, dossier review, and health authority engagement.
• Excellent project leadership, stakeholder management, and communication skills.
• Ability to manage multiple regulatory priorities in a fast-paced environment.

Responsibilities

• Own and develop regulatory strategy across significant programs ensuring alignment with objectives and requirements.
• Provide leadership on major regulatory decisions, including authority engagement models, submission strategies, and risk mitigation.
• Lead planning and execution of high-impact regulatory submissions with cross-functional teams and compliance.
• Develop and implement long-range development and lifecycle plans to optimize regulatory pathways and commercial outcomes.
• Collaborate with clinical, scientific and commercial teams to align regulatory strategy with timelines and market opportunities.
• Monitor regulatory landscape changes and provide strategic recommendations to adapt development and submission approaches.

Skills

Project management

Client-focused

Results orientation

Teamwork

Consulting skills

Interpersonal/ intercultural沟通

Critical thinking

English language proficiency

Education

Bachelor's degree in a Scientific or related field

Job description

Parexel in Australia seeks a senior Regulatory Affairs professional to own and develop regulatory strategies across major programs, ensuring alignment with business objectives and regulatory requirements.

You will lead authority engagement, manage submissions planning, lifecycle management, and collaborate with clinical, scientific and commercial teams to align regulatory activities with development timelines and market opportunities.