Regulatory Affairs Consultant – Core Team

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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

• Work within team environments or independently to deliver regulatory affairs consulting services. • Prioritize work and define steps to achieve project outcomes. • Produce quality work meeting project team lead and client expectations. • Serve as Project Lead for small projects or Work Stream Lead on larger projects. • Plan and set up projects, control project activities, and manage forecasting, financial entries, and invoicing when serving as Project Lead. • Act as the main client contact and ensure accurate project reporting. • Ensure project teams meet client quality and timeliness expectations. • Identify risks, escalate issues, ensure project-specific training compliance, and manage project financials. • Ensure project teams understand and work within contract scope. • Identify change-in-scope and add-on business opportunities. • Complete project close-out activities. • Implement Parexel consulting models and methodologies. • Provide technical and business consulting services within area of expertise. • Collaborate with colleagues and clients to resolve technical and process issues. • Assess client needs and develop processes and solutions. • Deliver assigned work and services that meet client expectations. • Prepare or deliver presentations and training with senior-colleague support. • Mentor junior staff. • Identify follow-on business opportunities and project-scope changes. • Build an industry network and communicate potential business leads. • Participate in project scoping calls and proposal preparation. • Complete timesheets, expense reports, CV maintenance, training compliance, deliverable archiving, and internal initiatives. • Define self-development activities and maintain relevant industry or scientific/technical association membership.

🎯 Requirements

• Several years of experience in an industry-related environment. • Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline. • Advanced Degree Preferred. • Project management knowledge. • Client-focused approach to work. • Results orientation. • Teamwork and collaboration skills. • Consulting skills. • Excellent interpersonal and intercultural communication skills, written and verbal. • Critical thinking and problem-solving skills. • Proficiency in the local language and extensive working knowledge of English.