Regulatory Affairs Consultant – E2E Labelling
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Job Description
Regulatory Affairs Consultant managing end-to-end labelling lifecycle and ensuring compliance for global pharmaceutical operations. Collaborating with teams across regions to drive effective labelling strategies.
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
Requirements:
- 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 BfArM
- 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:
- Competitive salary
- Flexible working hours
- Professional development opportunities
- Remote work options
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