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Parexel

Senior Regulatory Affairs Associate – RA Generalist

Parexel

Senior Regulatory Affairs Associate ensuring compliance in local health authority interactions for clinical trials at Parexel. Managing documentation and coordinating with regulatory teams for project success in the healthcare industry.

Posted 8/3/2026full-timeNorth Ryde • 🇦🇺 AustraliaSeniorWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in project execution and regulatory compliance, with a strong focus on post-authorization lifecycle maintenance and local regulatory requirements. Proficient in managing documentation and impact assessments while fostering teamwork and effective communication.

Highest-signal resume keywords
Project Management KnowledgeRegulatory CompliancePost-Authorization Lifecycle MaintenanceIntercultural Communication SkillsImpact Assessment Coordination

ATS Keywords

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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills
Project ExecutionRegulatory KnowledgeImpact Assessment ManagementDocument ManagementTechnical Change Coordination
Soft Skills
Client-Focused ApproachResults OrientationTeamworkCritical ThinkingProblem-Solving
Tools & Technologies
Document Management ToolsInternal SystemsExternal Platforms
Certifications & Qualifications
Bachelor’s Degree in a Scientific or Technical Discipline
Industry Keywords
Regulatory TeamsLocal Regulatory RequirementsHA InspectionsAustraliaNew Zealand

About the role

Key responsibilities & impact
  • Project Execution
  • Previous experience working in industry in support of Global and/or local Regulatory teams
  • Strong knowledge of post-authorization lifecycle maintenance procedures
  • Use of document management tools (internal systems) and external platforms
  • Prepare, organize and coordinate local specific documentation
  • Ability to manage/coordinate impact assessments for technical changes impacting marketing authorization
  • Stay updated on local regulatory requirements, and guidelines
  • Maintain regulatory compliance and support HA inspections
  • Works effectively within a team environment

Requirements

What you’ll need
  • More than 3-5 + years of experience in an industry-related environment in Australia including New Zealand
  • Project management knowledge
  • Client-focused approach to work
  • Results orientation
  • Teamwork and collaboration 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
  • Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline

Benefits

Comp & perks
  • Health insurance
  • Flexible work arrangements