Merck & Co., Inc.
Senior Specialist Regulatory Affairs CMC(m/w/x)
Full-timeWith HomeofficeSenior
Schwabenheim an der Selz
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313167 MSDAnimalHealthInnovation
Senior Specialist, Global Regulatory Affairs(m/w/x)
Schwabenheim an der Selz
Full-timeWith Home OfficeSenior
Nejo AI Summary
Implementing new veterinary regulations for animal health products, updating packaging and preparing marketing authorizations. University degree in Veterinary Medicine, multi-year animal health regulatory experience, and Veeva Vault proficiency required. 13 monthly salaries, target bonus.
Requirements
- University degree in Veterinary Medicine
- Multi-year regulatory experience in animal health
- Excellent communication skills
- Proficiency in English and MS Office
- Proficiency with Veeva Vault
- Result-oriented and well-structured working style
- Strong interpersonal skills and sound judgement
- Attentiveness to details
- Experience in Drug Regulatory Affairs
- Project Management skills
- Ability to work across borders
Tasks
- Represent Global Regulatory Affairs in portfolio optimization projects
- Implement new veterinary regulations and update packaging materials
- Organize documents and data for marketing authorizations
- Ensure materials align with the licensing strategy
- Prepare technical statements with internal and external experts
- Coordinate updates for product literature, leaflets, and labels
- Manage regulatory submissions and respond to authority inquiries
- Assess post-approval changes and provide filing strategies
- Maintain regulatory information to ensure ongoing compliance
- Develop technical knowledge of pharmaceutical product development
- Communicate potential regulatory issues to management
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- MS office
- Veeva Vault
Benefits
Flexible Working
- Flexible working hours
- Hybrid working model
Additional Allowances
- 13 monthly salaries
Bonuses & Incentives
- Target bonus
Retirement Plans
- Attractive company pension scheme
More Vacation Days
- 30 days holiday entitlement
Learning & Development
- Internal training opportunities
- Training on the job
Career Advancement
- Promotion opportunities
Other Benefits
- International co-operations
- Medicinal product development insights
- Working across borders
Purpose-Driven Work
- Process design contribution
Parking & Commuter Benefits
- Free car parking
Generous Parental Leave
- Paid Parental Time Off
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of 3167 MSDAnimalHealthInnovation 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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313167 MSDAnimalHealthInnovation
Senior Specialist, Global Regulatory Affairs(m/w/x)
Schwabenheim an der Selz
Full-timeWith Home OfficeSenior
Nejo AI Summary
Implementing new veterinary regulations for animal health products, updating packaging and preparing marketing authorizations. University degree in Veterinary Medicine, multi-year animal health regulatory experience, and Veeva Vault proficiency required. 13 monthly salaries, target bonus.
Requirements
- University degree in Veterinary Medicine
- Multi-year regulatory experience in animal health
- Excellent communication skills
- Proficiency in English and MS Office
- Proficiency with Veeva Vault
- Result-oriented and well-structured working style
- Strong interpersonal skills and sound judgement
- Attentiveness to details
- Experience in Drug Regulatory Affairs
- Project Management skills
- Ability to work across borders
Tasks
- Represent Global Regulatory Affairs in portfolio optimization projects
- Implement new veterinary regulations and update packaging materials
- Organize documents and data for marketing authorizations
- Ensure materials align with the licensing strategy
- Prepare technical statements with internal and external experts
- Coordinate updates for product literature, leaflets, and labels
- Manage regulatory submissions and respond to authority inquiries
- Assess post-approval changes and provide filing strategies
- Maintain regulatory information to ensure ongoing compliance
- Develop technical knowledge of pharmaceutical product development
- Communicate potential regulatory issues to management
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- MS office
- Veeva Vault
Benefits
Flexible Working
- Flexible working hours
- Hybrid working model
Additional Allowances
- 13 monthly salaries
Bonuses & Incentives
- Target bonus
Retirement Plans
- Attractive company pension scheme
More Vacation Days
- 30 days holiday entitlement
Learning & Development
- Internal training opportunities
- Training on the job
Career Advancement
- Promotion opportunities
Other Benefits
- International co-operations
- Medicinal product development insights
- Working across borders
Purpose-Driven Work
- Process design contribution
Parking & Commuter Benefits
- Free car parking
Generous Parental Leave
- Paid Parental Time Off
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of 3167 MSDAnimalHealthInnovation 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
3167 MSDAnimalHealthInnovation
Industry
Pharmaceuticals
Description
The company embraces the value of bringing diverse, talented, and committed people together to foster innovation in an inclusive environment.
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