Regulatory Affairs Consultant

This is a fully remote position, open to applicants in Australia.

📋 Description

• Take charge of and shape the regulatory strategy across key programs or portfolios, ensuring alignment with both business goals and regulatory standards.

• Provide leadership on critical regulatory decisions, including models for authority engagement, submission strategies, and approaches to risk mitigation.

• Direct the planning and execution of significant regulatory submissions, coordinating cross-functional teams and ensuring adherence to regulatory requirements.

• Develop and implement long-term development and lifecycle management plans that enhance regulatory pathways and commercial success.

• Collaborate with clinical, scientific, and commercial teams to ensure regulatory strategy aligns with development timelines and market opportunities.

• Keep abreast of changes in the regulatory landscape and offer strategic recommendations for adapting development and submission strategies.

⛳️ Requirements

• Extensive experience in Regulatory Affairs, specifically in supporting Australian product development and lifecycle management.

• Demonstrated experience in leading or assisting with interactions with health authorities and regulatory processes.

• Strong comprehension of Marketing Authorisation Applications (MAAs) and the requirements for CTD/eCTD dossiers.

• Experience in preparing and reviewing regulatory documentation, including Module 1 content and materials for health authority briefings.

• Proven expertise in developing regulatory strategies, reviewing dossiers, and engaging with health authorities.

• Exceptional skills in project leadership, stakeholder management, and communication.

• Ability to juggle multiple regulatory priorities while achieving high-quality results in a fast-paced environment.

• Knowledge of project management principles.

• Client-focused work ethic.

• Strong results orientation.

• Ability to work collaboratively and as part of a team.

• Proficient consulting skills.

• Excellent interpersonal and intercultural communication skills, both in writing and verbally.

• Strong critical thinking and problem-solving abilities.

• Proficient in the local language and possess extensive working knowledge of the English language.

• At least 7+ years of experience in an industry-related setting with in-depth knowledge of Australian regulatory practices.

• A minimum of a Bachelor’s Degree in a scientific or related field of study.

🏝️ Benefits

• Competitive salary and comprehensive benefits package.

• Opportunities for professional development and career advancement.

• A collaborative and innovative work environment.

• Flexible work arrangements.