Regulatory Affairs Consultant, German, French

🔥 37 minutes ago

🇨🇭 Switzerland – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New 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

💼 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

• Develop, contribute to, and review content and format for regulatory submissions according to Swiss regulatory guidelines • Prepare and manage major and minor submissions, PSURs, label changes, CMC variations, post-approval commitments, variations, and notifications • Collaborate with Swiss regulatory, Global Regulatory Science, Regulatory CMC, and cross-functional project teams to develop and execute regulatory strategy • Coordinate regulatory submission aspects for assigned projects and programs • Maintain Swiss labeling, including SmPC, PIL, artwork, and packaging in local languages • Work independently and collaboratively within project teams to achieve group goals • Support the Head of Regulatory Affairs Switzerland in regulatory activities

🎯 Requirements

• University Degree in Life Sciences or related discipline • 5-8+ years of professional experience in Regulatory Affairs (Marketing Authorization Applications and post-approval variations) • Strong, current knowledge of Swissmedic regulations (mandatory) • Proven experience in preparing major regulatory submissions and variation packages to Swissmedic • Strong experience with CTD format and eCTD submission builds • Fluent spoken and written German, French and English • Experience in biologics and vaccines development - preferred • Knowledge of Rare Diseases, Autoimmune Diseases, or Oncology therapeutic areas - preferred