Parexel

Overview As a Regulatory Affairs Consultant, you will shape labeling strategy across markets and drive global alignment of product information for our pharmaceutical portfolio. You work within Regulatory Affairs to ensure compliant labeling throughout the lifecycle, from initial assessment to post-approval updates. The role is flexible in location, with a focus on coordinating global labeling activities across time zones. You will partner with regional teams to maintain accurate labels and support harmonization initiatives, delivering timely regulatory submissions. This position offers meaningful impact by advancing patient access to safe, well-communicated therapies.

Verantwortungsbereiche Manage end-to-end labeling lifecycle (assessment, implementation, post-approval maintenance) Provide technical expertise for country-specific labeling requirements Execute labeling operations globally with precision Work in a follow-the-sun model to ensure timely labeling activities Prepare and review labeling documents for regulatory submissions and variations Maintain labeling databases and tracking systems Support global labeling harmonization initiatives Collaborate with regional regulatory teams for local compliance Monitor regulatory intelligence related to labeling requirements Zentrale Anforderungen University degree in life science A few years of experience in biotech/pharmaceutical industry Labelling/regulatory experience with global responsibilities Experience with CCDS development and maintenance Strong understanding of regulatory labeling across

multiple markets Direct experience working with Swissmedic Excellent attention to detail and organizational skills Experience leading teams in a matrix organization Ability to work effectively in a global, virtual team environment Fluent in German and English (written and spoken) Attention to detail Strong organizational skills Cross-functional collaboration Labeling lifecycle management CCDS development and maintenance Regulatory labeling requirements across multiple markets