Fresenius Kabi Deutschland GmbH
Regulatory Compliance Specialist Enteral Nutrition(m/w/x)
Full-timeOn-siteExperienced
Bad Homburg vor der Höhe
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IQIQVIA RDS GmbH
Regulatory Affairs Specialist(m/w/x)
Frankfurt am Main
Full-timeOn-siteExperienced
Nejo AI Summary
Leading regulatory submission processes for medicinal products at global clinical research provider. 3+ years EU regulatory affairs experience for medicinal products, with DACH pharmaceutical legislation knowledge required. Daily interaction with Health Authorities.
Requirements
- Bachelor’s degree in Life Sciences or equivalent professional background
- 3+ years of experience in EU regulatory affairs for medicinal products
- Experience within a large regulatory organization
- Knowledge of pharmaceutical legislation and regulatory requirements in Germany, Switzerland, and Austria
- Excellent organizational skills and attention to detail
- Strong communication skills and collaborative working style
- Fluent written and verbal communication skills in German and English
- Strong computer skills, including MS Office; experience with regulatory information systems and artwork tools
Tasks
- Manage regulatory activities for medicinal products
- Ensure compliance with local requirements
- Prepare and coordinate regulatory submissions
- Collaborate with stakeholders on notifications, renewals, variations, and new applications
- Lead submission processes with local Health Authorities
- Follow up on submissions until approval
- Prepare and translate product labeling into German
- Review and approve artwork and promotional materials
- Support regulatory maintenance for multiple pharmaceutical products
- Monitor local pharmaceutical legislation and apply updates
Work Experience
- 3 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- MS Office
- regulatory information systems
- artwork tools
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of IQVIA RDS GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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IQIQVIA RDS GmbH
Regulatory Affairs Specialist(m/w/x)
Frankfurt am Main
Full-timeOn-siteExperienced
Nejo AI Summary
Leading regulatory submission processes for medicinal products at global clinical research provider. 3+ years EU regulatory affairs experience for medicinal products, with DACH pharmaceutical legislation knowledge required. Daily interaction with Health Authorities.
Requirements
- Bachelor’s degree in Life Sciences or equivalent professional background
- 3+ years of experience in EU regulatory affairs for medicinal products
- Experience within a large regulatory organization
- Knowledge of pharmaceutical legislation and regulatory requirements in Germany, Switzerland, and Austria
- Excellent organizational skills and attention to detail
- Strong communication skills and collaborative working style
- Fluent written and verbal communication skills in German and English
- Strong computer skills, including MS Office; experience with regulatory information systems and artwork tools
Tasks
- Manage regulatory activities for medicinal products
- Ensure compliance with local requirements
- Prepare and coordinate regulatory submissions
- Collaborate with stakeholders on notifications, renewals, variations, and new applications
- Lead submission processes with local Health Authorities
- Follow up on submissions until approval
- Prepare and translate product labeling into German
- Review and approve artwork and promotional materials
- Support regulatory maintenance for multiple pharmaceutical products
- Monitor local pharmaceutical legislation and apply updates
Work Experience
- 3 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- MS Office
- regulatory information systems
- artwork tools
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of IQVIA RDS GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
IQVIA RDS GmbH
Industry
Healthcare
Description
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries.
Not a perfect match?
- Fresenius Kabi Deutschland GmbH
Regulatory Compliance Specialist Enteral Nutrition(m/w/x)
Full-timeOn-siteExperiencedBad Homburg vor der Höhe - Fresenius Kabi Deutschland GmbH
Regulatory Affairs Expert Enteral Nutrition(m/w/x)
Full-timeOn-siteSeniorBad Homburg vor der Höhe - Sanofi-Aventis Deutschland GmbH
Quality Assurance Specialist(m/w/x)
Full-timeTemporary contractOn-siteExperiencedFrankfurt am Main - Fresenius Kabi Deutschland GmbH
RA Operations Expert EN(m/w/x)
Full-timeOn-siteSeniorBad Homburg vor der Höhe - Sanofi-Aventis Deutschland GmbH
Audit and Inspection Specialist(m/w/x)
Full-timeTemporary contractOn-siteExperiencedFrankfurt am Main