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
Skills and Experienced required for the role:
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
Additional Information
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
We are seeking an experienced Regulatory Affairs Consultant specializing 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.
Parexel · Switzerland