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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 - Labelling
Job ID R0000039108 , GermanyWe are seeking an experiencedRegulatory Affairs Consultantspecializing in global labelling operations to join our growing Regulatory Affairs team. This role offers the opportunity to shape labelling strategy across multiple markets and drive global alignment of product information for pharmaceutical portfolio of our clients.
The role can be fully home based or office based.
Key Responsibilities:
Manageend-to-end labeling lifecycleincluding preliminary assessment, implementation, and post-approval maintenance
Provide innovation and technical expertise for the creation, maintenance, and implementation of labeling to meetcountry-specific regulatory requirements
Execute labeling operations globally with precision and efficiency
Participate in a'follow the sun' modelto 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
Skills and Experienced required for the role:
University degree in a life science discipline
A few yearsof experience in the biotech/pharmaceutical industry
Labelling/regulatory experiencewith 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 amatrix organizationis expected
Ability to work effectively in a global, virtual team environment
Fluent in German and English, written and spoken
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