Regulatory Affairs Consultant - Core Team

As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there. We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.

Responsibilities

Project Execution: works within team environment or independently delivering services; works within broad project guidelines and liaises with senior colleagues; prioritizes work and defines steps to achieve project outcomes; produces quality work meeting expectations; may serve as Project Lead for small projects or Work Stream Lead on larger projects; responsible for project planning, set-up, forecasting, financial entries, and invoicing; functions as main client contact and ensures accurate project reporting; ensures project team delivers quality and timeliness; ensures risk identification and issue escalation; ensures training compliance; manages project financials including revenue forecasts; ensures project team understands contract scope; identifies new opportunities through Change In Scope or add-on business; ensures timely project close-out. Consulting Activities and Relationship Management: implements consulting models and methodologies; provides technical/business consulting services; collaborates with colleagues and clients to resolve issues; interacts professionally at multiple levels; proactively assesses client needs and develops solutions; delivers work resulting in client satisfaction; may prepare/deliver presentations or training; mentors junior staff; identifies follow-on business opportunities. Business Development: builds network of industry colleagues; communicates new business leads; may participate in scoping calls/proposal preparation. Parexel-related Activities: meets established metrics; completes timesheets, expense reports, CV maintenance, training compliance, archiving; participates in internal initiatives; defines self-development activities to stay current

Requirements

Knowledge in Regulatory Affairs Activities, focusing on CTAs (Phase I-IV) for various Therapeutic Areas; Proficient in Regulations; 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; Several years of experience in an industry-related environment; Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline

Nice to have

Preferred experience: Phase I or Early Phase studies; Studies involving Medical Devices; GMOs; Radiopharmaceuticals; Biological Drugs; Labelling for Investigational Medicinal Products; Experience in Quality Documentation and CMC (Composition, Manufacturing and Control of Investigational Medicinal Products) could be a plus; Some knowledge in New Zealand (ideal); Advanced Degree Preferred

Benefits

Flexible work arrangements (remote work); Supportive and inclusive environment; Opportunities for career growth; Diverse and global client exposure; Learn from experts; Patient-led culture; Flexible Work Program; Bravo Recognition Program; Supportive culture for well-being