Boehringer Ingelheim
Senior Regulatory Affairs Manager CMC for NBE(m/w/x)
Full-timeOn-siteSenior
Ingelheim am Rhein, Biberach
from USD 80,000 - 100,000 / year
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BOBoehringer Ingelheim
Senior Regulatory Affairs Manager CMC for NCE(m/w/x)
Biberach, Ingelheim am Rhein
Full-timeOn-siteSenior
AI/ML
Nejo AI Summary
Global CMC regulatory management for small molecule projects and approved products. Master's degree and several years of CMC development, production, and QA/QC experience required. 4-day work week, company car for private use.
Requirements
- Master’s degree in life science disciplines
- Several years of CMC development experience
- Several years of pharmaceutical production experience
- Several years of quality control experience
- Several years of quality assurance experience
- Global CMC regulatory experience in small molecules
- Global CMC regulatory experience in drug-device combination products
- In-depth knowledge of international CMC regulatory requirements
- Track record of leading strategic initiatives
- Track record of driving regulatory strategy forward
- Proven ability to lead people in cross-functional teams
- Proven ability to motivate people in cross-functional teams
- Proven ability to set directions in cross-functional teams
- Proven ability to manage changes in cross-functional teams
- Inter-disciplinary mindset
- Innovative thinking
- Strategic thinking
- Teamplayer
- Excellent organizational skills
- Excellent communication skills
- Strong prioritization capabilities
- Strong time management capabilities
- Fluency in English (written and spoken)
Tasks
- Manage global CMC regulatory activities for small molecule projects
- Manage global CMC regulatory activities for approved small molecule products
- Represent the department in global project teams
- Represent the department in global product teams
- Provide CMC regulatory advice on global requirements
- Provide CMC regulatory advice on submission strategies
- Provide CMC regulatory advice on seeking scientific advice
- Plan global Module 3 documentation for CTAs
- Define global Module 3 documentation for CTAs
- Review global Module 3 documentation for CTAs
- Compile global Module 3 documentation for CTAs
- Plan global Module 3 documentation for MAAs
- Define global Module 3 documentation for MAAs
- Review global Module 3 documentation for MAAs
- Compile global Module 3 documentation for MAAs
- Plan global Module 3 documentation for post-approval activities
- Define global Module 3 documentation for post-approval activities
- Review global Module 3 documentation for post-approval activities
- Compile global Module 3 documentation for post-approval activities
- Plan global Module 3 documentation for post-approval changes
- Define global Module 3 documentation for post-approval changes
- Review global Module 3 documentation for post-approval changes
- Compile global Module 3 documentation for post-approval changes
- Plan global Module 3 documentation for renewals
- Define global Module 3 documentation for renewals
- Review global Module 3 documentation for renewals
- Compile global Module 3 documentation for renewals
- Guide project teams in preparing global registration documents
- Guide project teams in preparing responses to health authorities
- Review CMC documentation for in-licensing products
- Drive innovative regulatory strategies
- Drive acceleration of regulatory strategies
- Utilize AI tools for regulatory strategies
- Contribute to interdisciplinary strategic projects internally
- Represent Boehringer Ingelheim in industry organizations externally
- Stay up-to-date on global CMC regulatory environment
- Monitor developments in strategically important areas
- Assess impact of developments on Boehringer Ingelheim
- Provide critical insights to Regulatory Affairs colleagues
- Provide critical insights to other key functions
- Coach less experienced colleagues
- Deputize for the team lead when needed
Work Experience
- approx. 4 - 6 years
Education
- Master's degree
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- ICH
- FDA
- PMDA
- EU
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Boehringer Ingelheim 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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BOBoehringer Ingelheim
Senior Regulatory Affairs Manager CMC for NCE(m/w/x)
Biberach, Ingelheim am Rhein
Full-timeOn-siteSenior
AI/ML
Nejo AI Summary
Global CMC regulatory management for small molecule projects and approved products. Master's degree and several years of CMC development, production, and QA/QC experience required. 4-day work week, company car for private use.
Requirements
- Master’s degree in life science disciplines
- Several years of CMC development experience
- Several years of pharmaceutical production experience
- Several years of quality control experience
- Several years of quality assurance experience
- Global CMC regulatory experience in small molecules
- Global CMC regulatory experience in drug-device combination products
- In-depth knowledge of international CMC regulatory requirements
- Track record of leading strategic initiatives
- Track record of driving regulatory strategy forward
- Proven ability to lead people in cross-functional teams
- Proven ability to motivate people in cross-functional teams
- Proven ability to set directions in cross-functional teams
- Proven ability to manage changes in cross-functional teams
- Inter-disciplinary mindset
- Innovative thinking
- Strategic thinking
- Teamplayer
- Excellent organizational skills
- Excellent communication skills
- Strong prioritization capabilities
- Strong time management capabilities
- Fluency in English (written and spoken)
Tasks
- Manage global CMC regulatory activities for small molecule projects
- Manage global CMC regulatory activities for approved small molecule products
- Represent the department in global project teams
- Represent the department in global product teams
- Provide CMC regulatory advice on global requirements
- Provide CMC regulatory advice on submission strategies
- Provide CMC regulatory advice on seeking scientific advice
- Plan global Module 3 documentation for CTAs
- Define global Module 3 documentation for CTAs
- Review global Module 3 documentation for CTAs
- Compile global Module 3 documentation for CTAs
- Plan global Module 3 documentation for MAAs
- Define global Module 3 documentation for MAAs
- Review global Module 3 documentation for MAAs
- Compile global Module 3 documentation for MAAs
- Plan global Module 3 documentation for post-approval activities
- Define global Module 3 documentation for post-approval activities
- Review global Module 3 documentation for post-approval activities
- Compile global Module 3 documentation for post-approval activities
- Plan global Module 3 documentation for post-approval changes
- Define global Module 3 documentation for post-approval changes
- Review global Module 3 documentation for post-approval changes
- Compile global Module 3 documentation for post-approval changes
- Plan global Module 3 documentation for renewals
- Define global Module 3 documentation for renewals
- Review global Module 3 documentation for renewals
- Compile global Module 3 documentation for renewals
- Guide project teams in preparing global registration documents
- Guide project teams in preparing responses to health authorities
- Review CMC documentation for in-licensing products
- Drive innovative regulatory strategies
- Drive acceleration of regulatory strategies
- Utilize AI tools for regulatory strategies
- Contribute to interdisciplinary strategic projects internally
- Represent Boehringer Ingelheim in industry organizations externally
- Stay up-to-date on global CMC regulatory environment
- Monitor developments in strategically important areas
- Assess impact of developments on Boehringer Ingelheim
- Provide critical insights to Regulatory Affairs colleagues
- Provide critical insights to other key functions
- Coach less experienced colleagues
- Deputize for the team lead when needed
Work Experience
- approx. 4 - 6 years
Education
- Master's degree
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- ICH
- FDA
- PMDA
- EU
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Boehringer Ingelheim 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
Boehringer Ingelheim
Industry
Pharmaceuticals
Description
The company is focused on delivering lasting value to patients through innovative therapies and early clinical development.
Not a perfect match?
- Boehringer Ingelheim
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