Jobs at Parexel
Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Regulatory Affairs Consultant - on-site in Basel (German and French language skills)
Job ID R0000046397 Basel, Canton of Basel-City, SwitzerlandWe are seeking an experienced Regulatory Affairs Consultant to join our global Regulatory Affairs team. In this role, you will develop, review, and manage regulatory submissions and compliance activities for pharmaceutical products throughout their lifecycle—from clinical development through post-market activities. You will work collaboratively with cross-functional teams while demonstrating strong independent judgment and operational expertise.
This is a client dedicated role and you will be working from an office 2 days a week (Basel).
Key Responsibilities:
Develop, contribute to, and review content and format for regulatory submissions according to Swiss regulatory guidelines, including:
- Major and minor submissions
- Periodic Safety Update Reports (PSURs)
- Label changes and Chemistry, Manufacturing & Controls (CMC) variations
- Post-approval commitments, variations, and notifications
- Collaborate with the Swiss regulatory team, Global Regulatory Science, Regulatory CMC, and cross-functional project teams to develop and execute regulatory strategy throughout the product lifecycle, including clinical development, post-market activity, and life cycle management.
- Coordinate regulatory submission aspects relevant to assigned projects and programs.
- Maintain Swiss labeling (SmPC, PIL, artwork, and packaging in local languages) in alignment with regulatory requirements and global labeling/core datasheet standards.
- Demonstrate strong ability to work both independently and collaboratively within project teams to achieve group goals.
- Support the Head of Regulatory Affairs Switzerland in regulatory activities as appropriate.
Skills and Qualifications:
- 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
- Experience in biologics and vaccines development - preferred
- Knowledge of Rare Diseases, Autoimmune Diseases, or Oncology therapeutic areas - preffered
- Fluent spoken and written German, French and English
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