Boehringer Ingelheim
Senior Regulatory Affairs Manager CMC for NCE(m/w/x)
Full-timeOn-siteSenior
Biberach, Ingelheim am Rhein
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BOBoehringer Ingelheim
Senior Regulatory Affairs Manager CMC for NBE(m/w/x)
Ingelheim am Rhein, Biberach
from USD 80,000 - 100,000 / year
Full-timeOn-siteSenior
AI/ML
Nejo AI Summary
Managing CMC regulatory activities for biologicals, including advice on global requirements and submission strategies. Several years of global CMC regulatory experience for biologicals and drug-device combination products required. Unlimited PTO, 401k matching.
Requirements
- Master's degree in Biotechnology, Biochemistry, Pharmacy, Chemistry, or Biology
- Experience in CMC development and/or production/control of biologicals
- Several years' experience in global CMC regulatory for biologicals and drug-device combination products
- Experience in Antibody-Drug Conjugate (ADCs) advantageous
- In-depth knowledge of international CMC regulatory requirements
- Track record of leading strategic initiatives
- Driving regulatory strategy
- Proven ability to lead and motivate people in cross-functional teams
- Set direction and manage changes
- Inter-disciplinary mindset
- Innovative and strategic thinking
- Team player
- Excellent organizational skills
- Excellent communication skills
- Strong prioritization capabilities
- Strong time management capabilities
Tasks
- Manage CMC regulatory activities for biologicals
- 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
- Define global Module 3 documentation
- Review global Module 3 documentation
- Compile global Module 3 documentation for CTAs
- Compile global Module 3 documentation for MAAs
- Compile global Module 3 documentation for post-approval activities
- Compile global Module 3 documentation for post-approval changes
- Compile global Module 3 documentation for renewals
- Guide project teams in preparing 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
- 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
Benefits
Healthcare & Fitness
- Health insurance
Retirement Plans
- 401k matching
More Vacation Days
- Unlimited PTO
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 NBE(m/w/x)
Ingelheim am Rhein, Biberach
from USD 80,000 - 100,000 / year
Full-timeOn-siteSenior
AI/ML
Nejo AI Summary
Managing CMC regulatory activities for biologicals, including advice on global requirements and submission strategies. Several years of global CMC regulatory experience for biologicals and drug-device combination products required. Unlimited PTO, 401k matching.
Requirements
- Master's degree in Biotechnology, Biochemistry, Pharmacy, Chemistry, or Biology
- Experience in CMC development and/or production/control of biologicals
- Several years' experience in global CMC regulatory for biologicals and drug-device combination products
- Experience in Antibody-Drug Conjugate (ADCs) advantageous
- In-depth knowledge of international CMC regulatory requirements
- Track record of leading strategic initiatives
- Driving regulatory strategy
- Proven ability to lead and motivate people in cross-functional teams
- Set direction and manage changes
- Inter-disciplinary mindset
- Innovative and strategic thinking
- Team player
- Excellent organizational skills
- Excellent communication skills
- Strong prioritization capabilities
- Strong time management capabilities
Tasks
- Manage CMC regulatory activities for biologicals
- 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
- Define global Module 3 documentation
- Review global Module 3 documentation
- Compile global Module 3 documentation for CTAs
- Compile global Module 3 documentation for MAAs
- Compile global Module 3 documentation for post-approval activities
- Compile global Module 3 documentation for post-approval changes
- Compile global Module 3 documentation for renewals
- Guide project teams in preparing 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
- 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
Benefits
Healthcare & Fitness
- Health insurance
Retirement Plans
- 401k matching
More Vacation Days
- Unlimited PTO
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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Director AS&T Projects & Strategy(m/w/x)
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(Associate) Director Protein & ADC Drug Product(m/w/x)
Full-timeOn-siteSeniorMainz, München