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
Regional Regulatory Lead(m/w/x)
Ingelheim am Rhein
from USD 80,000 - 100,000 / year
Full-timeOn-siteExperienced
Nejo AI Summary
EU/Canada regulatory strategy for human pharma products, including pediatric development and clinical trial applications. Several years of hands-on RA experience in the region required. Unlimited PTO, 401k matching.
Requirements
- Master’s or bachelor’s degree in pharmacy or life sciences
- Several years of pharmaceutical industry experience in Regulatory Affairs in Human Pharma
- Experience in functions outside of RA highly desirable
- Regulatory affairs 'hands on' experience in the region
- Understanding of cultures and their impact
- Practical experience handling new developments
- Practical experience handling registrations
- Practical experience handling maintenance of registered products
- Outstanding ability in negotiating
- Outstanding ability in managing projects
- Knowledge of interacting with health authorities
- Capability to apply scientific expertise
- Readiness to apply scientific expertise
- Capability to participate in informed scientific dialogues
- Readiness to participate in informed scientific dialogues
- Critical thinking
- Aptitude to self-manage workload
- Ability to reorganize priorities
- Ability to meet tight deadlines
- Proficiency in English communication, verbal
- Proficiency in English communication, written
Tasks
- Provide robust regulatory strategy for assigned products/projects
- Guide maintenance and development needs in EUCAN region
- Address pediatric development requirements
- Manage clinical trial applications
- Plan and coordinate regulatory submissions for marketing authorization maintenance
- Oversee regulatory submissions for marketing authorization maintenance
- Organize meetings with regulatory authorities in EUCAN countries
- Schedule meetings with regulatory authorities in EUCAN countries
- Carry out in-person meetings with regulatory authorities
- Carry out remote meetings with regulatory authorities
- Contribute to Regulatory Excellence Team meetings
- Support development of worldwide regulatory strategies
- Act as interface for RA functions in ROPUs and OPUs in EUCAN
- Act as contact partner for RA functions in ROPUs and OPUs in EUCAN
- Liaise with Global RA for assigned products/projects
- Liaise with other cross-functional stakeholders for assigned products/projects
- Serve as EMA contact for products under EU centralized procedure
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
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
Regional Regulatory Lead(m/w/x)
Ingelheim am Rhein
from USD 80,000 - 100,000 / year
Full-timeOn-siteExperienced
Nejo AI Summary
EU/Canada regulatory strategy for human pharma products, including pediatric development and clinical trial applications. Several years of hands-on RA experience in the region required. Unlimited PTO, 401k matching.
Requirements
- Master’s or bachelor’s degree in pharmacy or life sciences
- Several years of pharmaceutical industry experience in Regulatory Affairs in Human Pharma
- Experience in functions outside of RA highly desirable
- Regulatory affairs 'hands on' experience in the region
- Understanding of cultures and their impact
- Practical experience handling new developments
- Practical experience handling registrations
- Practical experience handling maintenance of registered products
- Outstanding ability in negotiating
- Outstanding ability in managing projects
- Knowledge of interacting with health authorities
- Capability to apply scientific expertise
- Readiness to apply scientific expertise
- Capability to participate in informed scientific dialogues
- Readiness to participate in informed scientific dialogues
- Critical thinking
- Aptitude to self-manage workload
- Ability to reorganize priorities
- Ability to meet tight deadlines
- Proficiency in English communication, verbal
- Proficiency in English communication, written
Tasks
- Provide robust regulatory strategy for assigned products/projects
- Guide maintenance and development needs in EUCAN region
- Address pediatric development requirements
- Manage clinical trial applications
- Plan and coordinate regulatory submissions for marketing authorization maintenance
- Oversee regulatory submissions for marketing authorization maintenance
- Organize meetings with regulatory authorities in EUCAN countries
- Schedule meetings with regulatory authorities in EUCAN countries
- Carry out in-person meetings with regulatory authorities
- Carry out remote meetings with regulatory authorities
- Contribute to Regulatory Excellence Team meetings
- Support development of worldwide regulatory strategies
- Act as interface for RA functions in ROPUs and OPUs in EUCAN
- Act as contact partner for RA functions in ROPUs and OPUs in EUCAN
- Liaise with Global RA for assigned products/projects
- Liaise with other cross-functional stakeholders for assigned products/projects
- Serve as EMA contact for products under EU centralized procedure
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
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?
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