Regulatory Affairs Consultant

🔥 2 minutes ago

🇦🇺 Australia – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

🚔 Compliance

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 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

🎯 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 • 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 • At least 7+ years of experience in an industry-related environment with deep Australia regulatory expertise • Minimum of a Bachelor’s Degree in a Scientific or related area of study