At a Glance
- Tasks: Lead regulatory strategies and submissions for impactful projects in the healthcare sector.
- Company: Dynamic consultancy focused on regulatory affairs with a collaborative team culture.
- Benefits: Remote work flexibility, competitive salary, and opportunities for professional growth.
- Other info: Join a fast-paced environment with diverse teams and exciting challenges.
- Why this job: Make a difference in healthcare by shaping regulatory pathways and influencing market outcomes.
- Qualifications: 7+ years in regulatory affairs with strong leadership and communication skills.
The predicted salary is between 59400 - 72600 $ per year.
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/e CTD 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
- #LI-REMOTE
Regulatory Affairs Consultant - FSP in Gold Coast employer: Parexel
At Parexel, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters collaboration and innovation. Our Melbourne and Sydney locations provide a vibrant environment where Clinical Research Associates can thrive, with ample opportunities for professional growth and development. We are committed to maintaining a supportive atmosphere that values high-quality work and encourages our employees to build meaningful relationships within the clinical research community.
