Merck & Co., Inc.
Associate Director Global Pharmaceutical Development - (Animal Health R&D)(m/w/x)
Full-timeWith HomeofficeExperienced
Schwabenheim an der Selz
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313167 MSDAnimalHealthInnovation
Associate Director Global Regulatory Affairs Pharma Safety & Efficacy, New developments(m/w/x)
Schwabenheim an der Selz
Full-timeWith Home OfficeExperienced
Nejo AI Summary
Providing regulatory input for pharmaceutical safety and efficacy, preparing EU and global filing strategies. University degree in Veterinary Medicine and EU submissions experience required. Work with regional teams, coordinate multiple projects.
Requirements
- University degree in Veterinary Medicine
- Several years pharma product development experience
- Proven EU submissions and authority meetings experience
- Profound expertise in technical & procedural regulatory requirements
- Ability to coordinate multiple projects and priorities, meeting deadlines
- Ability to deal with multiple priorities
- Strong interpersonal skills
- Sound judgement
- Attentive to details
- Strong and effective communicator and negotiator
- Proficient in English
- German language skills are a plus
- Preference for equally qualified severely disabled individuals
- Adaptability
- Change Management
- Cross-Cultural Awareness
- Data Management
- Employee Training Programs
- FDA Regulations
- Pharmacovigilance
- Policy Implementation
- Regulatory Compliance
- Regulatory Labeling
- Regulatory Operations
- Regulatory Submissions
- Strategic Thinking
- Systems Development Lifecycle (SDLC)
- Vendor Management
Tasks
- Provide comprehensive regulatory input for pharmaceutical safety and efficacy
- Prepare regulatory filing strategies for EU and global markets
- Coordinate and manage safety, efficacy, and regulatory documentation
- Prepare and manage regulatory submissions and health authority responses
- Work closely with regional and local regulatory teams
- Enter and maintain regulatory information
- Monitor new regulatory guidance and framework changes
- Participate in industry and regulatory association working groups
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- English – Native
- German – Basic
Tools & Technologies
- FDA Regulations
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
Associate Director Global Regulatory Affairs Pharma Safety & Efficacy, New developments(m/w/x)
Schwabenheim an der Selz
Full-timeWith Home OfficeExperienced
Nejo AI Summary
Providing regulatory input for pharmaceutical safety and efficacy, preparing EU and global filing strategies. University degree in Veterinary Medicine and EU submissions experience required. Work with regional teams, coordinate multiple projects.
Requirements
- University degree in Veterinary Medicine
- Several years pharma product development experience
- Proven EU submissions and authority meetings experience
- Profound expertise in technical & procedural regulatory requirements
- Ability to coordinate multiple projects and priorities, meeting deadlines
- Ability to deal with multiple priorities
- Strong interpersonal skills
- Sound judgement
- Attentive to details
- Strong and effective communicator and negotiator
- Proficient in English
- German language skills are a plus
- Preference for equally qualified severely disabled individuals
- Adaptability
- Change Management
- Cross-Cultural Awareness
- Data Management
- Employee Training Programs
- FDA Regulations
- Pharmacovigilance
- Policy Implementation
- Regulatory Compliance
- Regulatory Labeling
- Regulatory Operations
- Regulatory Submissions
- Strategic Thinking
- Systems Development Lifecycle (SDLC)
- Vendor Management
Tasks
- Provide comprehensive regulatory input for pharmaceutical safety and efficacy
- Prepare regulatory filing strategies for EU and global markets
- Coordinate and manage safety, efficacy, and regulatory documentation
- Prepare and manage regulatory submissions and health authority responses
- Work closely with regional and local regulatory teams
- Enter and maintain regulatory information
- Monitor new regulatory guidance and framework changes
- Participate in industry and regulatory association working groups
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- English – Native
- German – Basic
Tools & Technologies
- FDA Regulations
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.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
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.
Not a perfect match?
- Merck & Co., Inc.
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