Regulatory Affairs Consultant - FSP

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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