Regulatory Affairs Consultant, Labelling – German Speaker

🔥 0 minutes ago

Apply Now

Find Similar Remote Jobs

Receive Emails For Remote Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

Healthcare Insurance • Biotechnology • Pharmaceuticals

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

• Manage end-to-end labeling lifecycle including preliminary assessment, implementation, and post-approval maintenance • Provide innovation and technical expertise for the creation, maintenance, and implementation of labeling to meet country-specific regulatory requirements • Execute labeling operations globally with precision and efficiency • Participate in a 'follow the sun' model to ensure timely execution of labelling activities across time zones • Prepare and review labelling documents for regulatory submissions and variations • Maintain labeling databases and tracking systems • Support global labelling harmonization initiatives • Collaborate with regional regulatory teams to ensure compliance with local requirements • Monitor regulatory intelligence related to labelling requirements

🎯 Requirements

• University degree in a life science discipline • A few years of experience in the biotech/pharmaceutical industry • Labelling/regulatory experience with global responsibilities • Experience with CCDS development and maintenance • Strong understanding of regulatory labelling requirements across multiple markets • Direct experience working with Swissmedic • Excellent attention to detail and organizational skills • Experience leading teams in a matrix organization is expected • Ability to work effectively in a global, virtual team environment • Fluent in German and English, written and spoken.

🏖️ Benefits

• Health insurance • Flexible work arrangements • Professional development opportunities