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Regulatory Affairs Consultant, Labelling – German Speaker
ParexelRegulatory Affairs Consultant managing end-to-end labeling lifecycle operations across global markets. Collaborating with regional teams to ensure compliance with varying regulatory requirements in the pharmaceutical industry.
ATS Keywords
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Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
labeling lifecycle managementregulatory submissionsCCDS developmentlabeling databasesregulatory compliancelabeling operationsregulatory intelligencepost-approval maintenancelabeling harmonizationtechnical expertise
Soft Skills
attention to detailorganizational skillsteam leadershipcollaborationglobal team effectiveness
Certifications & Qualifications
university degree in life science
Industry Keywords
biotechpharmaceuticalSwissmedicglobal responsibilitiesregulatory requirementsmatrix organizationcountry-specific regulationstime zone managementregional regulatory teamsinnovation
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- Health insurance
- Flexible work arrangements
- Professional development opportunities