Regulatory Affairs Consultant – Regulatory Generalist

🔥 15 hours ago

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 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

• Lead or support authoring, assembly, quality review, and submission management for IND Module 1 content and other U.S. administrative submission components • Maintain tables of contents and submission trackers covering content ownership, status, dependencies, approvals, and publishing readiness • Coordinate regulatory publishing, document management, asset management, and subject matter experts to deliver submission packages • Draft and coordinate FDA forms, cover letters, submission metadata, and administrative documentation • Manage review and approval workflows, resolve content or formatting gaps, and oversee publishing and submission handoffs • Support INDs, NDAs, supplements, amendments, and related health authority correspondence • Author and coordinate health authority meeting requests, briefing documents, meeting packages, and administrative components • Coordinate FDA information request responses, reviews, timelines, and final submissions • Archive health authority correspondence and meeting records with indexing, version control, and traceability • Prepare and coordinate IND and NDA lifecycle submissions, including protocol amendments, investigator updates, CMC amendments, Investigator’s Brochure updates, annual reports, supplements, and post-approval submissions • Author or coordinate regulatory content for PADERs, PBRERs/PSURs, DSURs, Investigator’s Brochures, and periodic or safety-related reports • Conduct regulatory intelligence searches and synthesize findings into decision-oriented presentations • Prepare materials for Global Regulatory Team, governance, and alliance meetings • Coordinate agendas, functional updates, decisions, actions, and program milestone alignment • Represent Regulatory Affairs in Global Regulatory Team, clinical trial, partner, and alliance meetings • Collaborate with Clinical, CMC, Nonclinical, Safety, Quality, Commercial, Regulatory Operations, Publishing, and Asset Management teams • Maintain U.S. regulatory archive logs and file submissions, correspondence, and partner documentation • Upload and manage correspondence and regulatory records from global partners • Maintain indexing, metadata, version control, traceability, and inspection-ready records using RIM, EDMS, and applicable tools • Maintain Form FDA 1572 waiver and clinical documentation trackers, author waiver requests, and support related submissions • Conduct regulatory reviews of study start-up documentation to support IND-level compliance

🎯 Requirements

• 5+ years of regulatory affairs experience within the pharmaceutical or biotechnology industry • Hands-on experience with IND Module 1 authoring, submission assembly, TOC tracking, and coordination with regulatory publishing or submission operations • Direct experience with IND lifecycle maintenance, including protocol amendments, investigator updates, CMC amendments, and Investigator’s Brochure updates • Experience supporting NDA submissions and lifecycle maintenance, including annual reports and post-approval activities • Experience authoring or coordinating health authority meeting requests, briefing documents, FDA information request responses, and health authority correspondence • Experience contributing to PADERs, DSURs, PSURs/PBRERs, Investigator’s Brochures, or associated regulatory sections • Experience conducting regulatory intelligence research and presenting guidelines or precedents to inform regulatory planning or strategy • Proven ability to prepare Global Regulatory Team, governance, or alliance meeting materials and coordinate cross-functional inputs • Experience working across Clinical, CMC, Nonclinical, Safety, Quality, Regulatory Operations, Publishing, and related functions • Strong regulatory writing, document coordination, and submission management capabilities • Ability to translate guidelines and regulatory precedents into concise, decision-focused presentations • Excellent organization and project management skills across multiple assets, deadlines, contributors, and review cycles • High attention to detail and commitment to submission quality, document control, and inspection readiness • Client-focused, consultative approach with strong interpersonal and cross-cultural communication skills • Ability to work effectively across matrixed, cross-company, and alliance environments • Critical thinking, problem-solving, results orientation, and sound judgment in a fast-moving environment • Excellent written and verbal English communication skills; proficiency in the local language, where applicable • Working knowledge of RIM, EDMS, and electronic submission processes is strongly preferred • Bachelor’s degree in a scientific, technical, or related discipline required • Candidates located in the Eastern or Central time zones of the United States or Canada are preferred

🏖️ Benefits

• Paid time off • 401(k) match • Life insurance • Health insurance • Additional benefit offerings in accordance with applicable plans • Potential eligibility for additional incentives, bonuses, or other compensation programs • Flexible work environment • Growth opportunities