Regulatory Affairs Consultant - FSP

Parexel; Australia; Remote; AUD 140,000 - 190,000; Full time

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.

Skills

Regulatory strategy

HA interactions

CTD/eCTD knowledge

Regulatory submissions

Cross-functional leadership

Project management

Stakeholder management

Communication skills

Education

Bachelor's degree in science

Job description

Own and develop regulatory strategy across significant programs or portfolios, ensuring alignment with business objectives and regulatory requirements

Provide leadership on major regulatory decisions, including authority engagement models, submission strategies, and risk mitigation approaches

Lead the planning and execution of high-impact regulatory submissions, coordinating cross-functional teams and ensuring compliance with regulatory requirements

Develop and implement long-range development and lifecycle management plans that optimize regulatory pathways and commercial outcomes

Collaborate with clinical, scientific, and commercial teams to align regulatory strategy with development timelines and market opportunities

Monitor regulatory landscape changes and provide strategic recommendations to adapt development and submission approaches

Key Requirements

• Significant Regulatory Affairs experience supporting Australian product development and lifecycle management.
• Proven experience leading or supporting HA interactions and regulatory procedures.
• Strong understanding of Marketing Authorisation Applications (MAAs) and CTD/eCTD dossier requirements.
• Experience preparing and reviewing regulatory documentation, including Module 1 content and health authority briefing materials.
• Demonstrated 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 while delivering high-quality outcomes in a fast-paced environment.

Skills

• Project management knowledge
• Client-focused approach to work
• Results orientation
• Teamwork and collaboration skills
• Consulting skills
• Excellent interpersonal and intercultural communication skills, both written and verbal
• Critical thinking and problem-solving skills
• Proficiency in local language and extensive working knowledge of the English language

Knowledge and Experience

• At least 7+ years of experience in an industry-related environment with a deep Australia regulatory expertise

Education

• Minimum of a Bachelor's Degree in a Scientific or related area of study

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