3167 MSDAnimalHealthInnovation
Senior Specialist, Global Regulatory Affairs(m/w/x)
Full-timeWith HomeofficeSenior
Schwabenheim an der Selz
New Job?Nejo!
The AI Job Search Engine
MEMerck & Co., Inc.
Senior Specialist Regulatory Affairs CMC(m/w/x)
Schwabenheim an der Selz
Full-timeWith Home OfficeSenior
Nejo AI Summary
Coordinating documentation for biopharmaceutical product submissions and compliance at global biopharmaceutical manufacturer. Experience preparing sections for Common Technical Document, US supplements, and EU variations required. Work in international teams on complex projects.
Requirements
- Minimum B.S. in pharmacy, chemistry, or science degree
- Experience in preparing CMC sections in Common Technical Document format
- Experience in preparing US supplements and EU variations
- Experience critically reviewing detailed scientific information
- Good understanding of manufacturing, analytical, quality assurance, and R&D
- Strong written and verbal communication skills in multicultural settings
- High level of professionalism
- Proficient in English
- Accountability
- Adaptability
- Detail-oriented
- Mentorship
- Project management
- Regulatory compliance
Tasks
- Collaborate with manufacturing, quality, technical support, and R&D teams
- Coordinate with the main project responsible CMC AD
- Ensure all important CMC documentation is complete
- Support the development of standard processes for regulatory compliance
- Participate in complex projects related to regulatory processes
- Maintain knowledge of EMA, FDA, VICH, and country-specific CMC guidelines
- Provide documentation for various countries and maintain submission documents
- Assist senior team members during the LOQ-A phase by tracking progress
- Support project activities like Gap & Risk assessments and kick-off meetings
- Check submitted or registered status with CORAs and compile necessary variations
- Participate in new product development teams and other project teams
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Merck & Co., Inc. 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.
Not a perfect match?
- Merck & Co., Inc.
Senior Specialist Regulatory Affairs – CMC(m/w/x)
Full-timeTemporary contractWith HomeofficeSeniorSchwabenheim an der Selz - MSDAnimalHealthInnovation
Specialist Regulatory Affairs-CMC(m/w/x)
Full-timeTemporary contractWith HomeofficeJuniorSchwabenheim an der Selz - Merck & Co., Inc.
Associate Director Global Pharmaceutical Development - (Animal Health R&D)(m/w/x)
Full-timeWith HomeofficeExperiencedSchwabenheim an der Selz - Fusion Consulting
Senior Functional Consultant – Veeva Network Implementation(m/w/x)
Full-timeWith HomeofficeSeniorMainz
MEMerck & Co., Inc.
Senior Specialist Regulatory Affairs CMC(m/w/x)
Schwabenheim an der Selz
Full-timeWith Home OfficeSenior
Nejo AI Summary
Coordinating documentation for biopharmaceutical product submissions and compliance at global biopharmaceutical manufacturer. Experience preparing sections for Common Technical Document, US supplements, and EU variations required. Work in international teams on complex projects.
Requirements
- Minimum B.S. in pharmacy, chemistry, or science degree
- Experience in preparing CMC sections in Common Technical Document format
- Experience in preparing US supplements and EU variations
- Experience critically reviewing detailed scientific information
- Good understanding of manufacturing, analytical, quality assurance, and R&D
- Strong written and verbal communication skills in multicultural settings
- High level of professionalism
- Proficient in English
- Accountability
- Adaptability
- Detail-oriented
- Mentorship
- Project management
- Regulatory compliance
Tasks
- Collaborate with manufacturing, quality, technical support, and R&D teams
- Coordinate with the main project responsible CMC AD
- Ensure all important CMC documentation is complete
- Support the development of standard processes for regulatory compliance
- Participate in complex projects related to regulatory processes
- Maintain knowledge of EMA, FDA, VICH, and country-specific CMC guidelines
- Provide documentation for various countries and maintain submission documents
- Assist senior team members during the LOQ-A phase by tracking progress
- Support project activities like Gap & Risk assessments and kick-off meetings
- Check submitted or registered status with CORAs and compile necessary variations
- Participate in new product development teams and other project teams
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Merck & Co., Inc. 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
Merck & Co., Inc.
Industry
Pharmaceuticals
Description
Das Unternehmen agiert als weltweit zuverlässiger Hersteller und Lieferant von Biopharmazeutika und beliefert Kunden und Patienten mit qualitativ hochwertigen Produkten.
Not a perfect match?
- 3167 MSDAnimalHealthInnovation
Senior Specialist, Global Regulatory Affairs(m/w/x)
Full-timeWith HomeofficeSeniorSchwabenheim an der Selz - Merck & Co., Inc.
Senior Specialist Regulatory Affairs – CMC(m/w/x)
Full-timeTemporary contractWith HomeofficeSeniorSchwabenheim an der Selz - MSDAnimalHealthInnovation
Specialist Regulatory Affairs-CMC(m/w/x)
Full-timeTemporary contractWith HomeofficeJuniorSchwabenheim an der Selz - Merck & Co., Inc.
Associate Director Global Pharmaceutical Development - (Animal Health R&D)(m/w/x)
Full-timeWith HomeofficeExperiencedSchwabenheim an der Selz - Fusion Consulting
Senior Functional Consultant – Veeva Network Implementation(m/w/x)
Full-timeWith HomeofficeSeniorMainz