Regulatory Affairs Consultant, Labelling – German Speaker

This is a fully remote position, open to applicants in Switzerland.

📋 Description

• Oversee the complete labeling lifecycle including initial assessment, execution, and ongoing maintenance post-approval.

• Deliver innovative solutions and technical knowledge for the development, upkeep, and execution of labeling that complies with country-specific regulatory standards.

• Carry out labeling operations on a global scale with accuracy and efficiency.

• Engage in a 'follow the sun' approach to ensure prompt execution of labeling tasks across various time zones.

• Prepare and evaluate labeling documents for regulatory submissions and variations.

• Manage labeling databases and tracking systems effectively.

• Assist with global labeling harmonization efforts.

• Work in collaboration with regional regulatory teams to guarantee adherence to local regulations.

• Keep abreast of regulatory intelligence concerning labeling requirements.

⛳️ Requirements

• Bachelor's degree in a life science field.

• Several years of experience in the biotech or pharmaceutical sector.

• Experience in labeling and regulatory affairs with global oversight.

• Familiarity with CCDS development and maintenance.

• Comprehensive understanding of regulatory labeling requirements across various markets.

• Direct experience collaborating with Swissmedic.

• Exceptional attention to detail and organizational capabilities.

• Proven experience leading teams within a matrix organization is required.

• Ability to operate effectively in a global, virtual team setting.

• Proficient in both German and English, in written and spoken forms.

🏝️ Benefits

• Health insurance.

• Flexible work arrangements.

• Opportunities for professional development.