Regulatory Affairs Consultant Labelling - German Speaker

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.

Key Responsibilities:
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