Senior Regulatory Affairs Associate – Regulatory Compliance

🔥 1 minute 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

• Function as SOP Coordinator for Global Regulatory Affairs controlled document revision cycles and ad-hoc revisions • Schedule Kick-Off Meetings, manage timelines, support document revisions, and maintain the GRA SOP revision tracker • Maintain knowledge and access to GSOP systems such as Veeva Vault and Monday.com • Support inspection readiness, including inspection calendar management, presentations, notifications, document requests, audit reports, CAPAs, and Deviations • Collaborate with Regulatory Intelligence and Pharmacovigilance teams on annual Regulatory Requirements Summary updates • Review and qualify Pharmacovigilance dashboard curated inbox notifications • Develop and distribute newsletters and compliance communications • Coordinate monthly regulatory milestone report updates with Regulatory Strategy • Coordinate and facilitate GRA staff, steering group, and departmental meetings • Maintain the GRA Collaboration Portal, contact lists, Outlook distribution lists, and organizational charts • Prepare KPI reports, including training metrics, and publish results on the GRA Collaboration Portal • Prepare and maintain compliance work instructions, SOP revisions, milestone reviews, and onboarding/offboarding materials • Provide meeting support, project reports, presentation materials, agendas, minutes, and follow-up on deliverables • Ensure activities meet timelines and escalate challenges or deviations • Maintain compliance performance metrics and generate management and project-team status reports • Participate in continuous improvement initiatives • Create, administer, and summarize surveys

🎯 Requirements

• Bachelor's degree in life sciences, scientific, or engineering field • 3+ years of general regulatory affairs experience and knowledge of the drug development process in the pharmaceutical industry • 3 years of audit and inspection exposure and/or experience • Strong oral and written communication skills • Solid working knowledge and understanding of the drug development process, laws, regulations, and guidelines including FDA, ICH, and other regulatory requirements • Experience working in regulatory affairs, healthcare, or a regulated environment • Experience with document management systems and regulatory compliance tools • Strong demonstrated experience with Microsoft Office programs (Word, Excel, PowerPoint, Outlook) • Ability to prioritize and work well in a fast-paced environment while multi-tasking and problem-solving • Preferred: Prior experience with new prescription drug/biologic applications (IND and/or NDA/BLA) • Preferred: Familiarity with electronic document management systems (EDMS)

🏖️ Benefits

• Health, Vision & Dental Insurance • Tuition Reimbursement • Vacation/Holiday/Sick Time • Flexible Spending & Health Savings Accounts • Work/Life Balance • 401(k) with Company match • Pet Insurance • Paid time off • Life insurance • Additional benefit offerings in accordance with applicable plans • Some roles may be eligible for additional incentives, bonuses, or other compensation programs