Senior Regulatory Affairs Associate – FSP

🔥 3 minutes ago

🇦🇺 Australia – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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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

• Provide post-authorization lifecycle management • Prepare, organize, and coordinate local-specific documentation to maintain regulatory compliance • Support health authority inspections as needed • Manage variations, renewals, PSURs, label updates, and CMC changes • Manage health authority interactions and responses to questions • Use internal document management tools and external platforms • Coordinate impact assessments for technical changes affecting marketing authorization • Work with medical, marketing, manufacturing sites, and other non-regulatory stakeholders • Monitor local regulatory requirements and guidelines and communicate requirements to GRA and other team members • Participate in regulatory meetings and share insights and best practices • Work independently and within a team environment to deliver project services • Prioritize work and complete assigned project activities within project guidelines • Produce quality work meeting project lead and client expectations • Potentially lead small-scale projects or workstreams on larger projects • Plan and set up projects; coordinate forecasting, financial entries, invoicing, reporting, training compliance, risk escalation, and close-out activities • Serve as the main client contact and ensure accurate project reporting • Identify change-in-scope and add-on business opportunities • Deliver consulting services within area of expertise • Identify project and client needs and propose solutions with senior staff • Support presentations, project scoping calls, and proposal preparation • Build industry relationships and communicate potential business leads • Complete timesheets, expense reports, CV maintenance, training compliance, deliverable archiving, and internal initiatives • Maintain relevant industry or scientific/technical association membership and define self-development activities

🎯 Requirements

• Strong knowledge and hands-on experience in Australia and New Zealand • Previous experience working in industry in support of Global and/or local Regulatory teams • Comprehensive understanding of regional and global regulatory requirements, guidelines and processes • In-depth expertise on local health authority management • Strong knowledge of post-authorization lifecycle maintenance procedures, including variations, renewals, and PSURs • Experience managing health authority interactions and responses to questions • Experience using document management tools and external platforms • Ability to prepare, organize, and coordinate local-specific documentation, including Module 1 • Ability to maintain national systems according to local legislation • Ability to manage or coordinate impact assessments for technical changes affecting marketing authorization • Ability to work with medical, marketing, manufacturing, and other non-regulatory stakeholders • Knowledge of local regulatory requirements and guidelines • Project management knowledge • Client-focused approach to work • Results orientation • Teamwork and collaboration skills • Excellent written and verbal interpersonal and intercultural communication skills • Critical thinking and problem-solving skills • Proficiency in the local language and extensive working knowledge of English • More than 4–5+ years of experience in an industry-related environment in Australia, including New Zealand • Minimum of a Bachelor's Degree in a Scientific or Technical Discipline

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