Senior Regulatory Affairs Associate – Generalist

🔥 1 hour ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

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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

• Maintain U.S. regulatory archive logs, record new submissions, archive regulatory authority correspondence, and manage global partner correspondence • Ensure regulatory records are indexed, version-controlled, complete, audit-ready, and compliant using RIM, EDMS, or applicable archiving tools • Maintain trackers for Form FDA 1572 waiver requests and clinical regulatory documentation • Conduct GLP reviews of study documentation to support IND-level compliance • Author 1572 waiver requests and support routine regulatory submissions for clinical investigators • Represent Regulatory Affairs in cross-functional clinical trial meetings with regulatory interpretation, updates, and risk assessments • Draft administrative components of submissions, including FDA forms, cover letters, metadata, and supporting documents • Build and organize electronic submission structures and manage internal workflows and approvals • Coordinate submission package delivery through publishing workflows and communicate with submission/publishing teams • Prepare materials for Global Regulatory Team, governance, and alliance meetings • Represent Regulatory Affairs in partner and alliance meetings, provide updates, and track action items • Contribute to FDA meeting requests, briefing documents, special designation applications, IND submissions, and amendments • Prepare, review, and submit PADERs, NDA Annual Reports, DSURs, and PBRERs • Track post-approval commitments, submission deadlines, and global regulatory requirements • Support lifecycle management activities and continued product compliance

🎯 Requirements

• 3+ years of related regulatory affairs 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 written and verbal interpersonal and intercultural communication skills • Critical thinking and problem-solving skills • Proficiency in the local language • Extensive working knowledge of English • Candidates located in the Eastern or Central time zones of the US or Canada are preferred