Senior Regulatory Affairs Associate

🔥 0 minutes ago

🇹🇷 Turkey – 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

• Provide local regulatory input to support regulatory strategies for new product registrations and lifecycle management activities • Monitor and communicate regulatory progress to stakeholders • Ensure compliance with local regulatory requirements and participate in policy-related activities with industry groups and trade associations • Maintain current knowledge of local regulatory requirements, guidelines, and industry developments • Support interactions with health authorities, partners, vendors, and commercial colleagues • Prepare, organize, and coordinate local regulatory documentation and country-specific submission components • Maintain local regulatory systems in accordance with legislation • Support implementation and interpretation of local legislation and regulations • Conduct promotional material review activities and operational regulatory execution • Partner with regional regulatory teams on regulatory submissions • Represent regulatory interests for local commercial operations and communicate regulatory approvals • Maintain regulatory information management systems and monitor compliance activities • Support timely renewals, post-approval submissions, regulatory commitments, labeling updates, translations, and promotional material review • Participate in in-person meetings with relevant Health Authority representatives

🎯 Requirements

• Relevant bachelor's degree or equivalent secondary education in a scientific discipline such as biology, chemistry, or a related field with a pharmacological focus • 5+ years of Turkish regulatory experience in a health authority-facing regulatory affairs role • Strong understanding of regional and global regulatory requirements, guidelines, and regulatory processes • Experience managing regulatory submissions, timelines, and cross-functional activities to support successful product registrations and compliance objectives • In-depth expertise in local health authority engagement and management • Strong communication, organization, time management, and problem-solving skills within a global environment • Fluent in the local language and English, both written and verbal • Advanced Microsoft Office skills

🏖️ Benefits

• Health, Vision & Dental Insurance • Vacation/Holiday/Sick Time • Flexible benefit portal • Flexible work arrangements • Growth opportunities

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