Evonik Operations GmbH
Senior Quality Manager for Product Lifecycle Projects(m/w/x)
Full-timeWith HomeofficeSenior
Darmstadt
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SUSUSONITY
Senior Manager GRA CMC Small Molecules Development(m/w/x)
Darmstadt
Full-time, Part-timeWith Home OfficeSenior
Nejo AI Summary
You will drive global CMC strategies for innovative drug developments, bridging the gap between technical experts and regulatory bodies to ensure life-changing medicines reach patients worldwide.
Requirements
- Degree in pharmacy, chemistry, life science, or Ph.D.
- Experience in pharmaceutical industry, Health Authorities, or CMC
- Experience with NCEs or drug-linkers for ADCs
- Knowledge of global regulatory CMC requirements
- Experience driving CMC activities and authoring dossiers
- Excellent written and spoken English skills
- Passion for team collaboration and problem-solving
Tasks
- Lead global regulatory CMC activities for clinical phases and launches
- Develop global regulatory CMC and dossier strategies
- Liaise between Global Regulatory Affairs and technical functions
- Author and approve regulatory quality documents like MAA and IND
- Translate country-specific regulations into technical requirements
- Advise technical experts on analytical and drug development
- Provide strategic CMC guidance to global regulatory functions
- Participate in interdisciplinary CMC and regulatory project teams
- Lead Health Authority interactions and meetings
- Perform expert CMC assessments for licensing and due diligence
Work Experience
5 years
Education
Bachelor's degree
Languages
English – Business Fluent
Tools & Technologies
New Chemical EntitiesAntibody Drug ConjugatesCMC dossiers
Benefits
Flexible Working
- •Hybrid work format
- •Remote work possible
Career Advancement
- •Access and growth opportunities
Other Benefits
- •Workplace accessibility accommodations
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of SUSONITY 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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SUSUSONITY
Senior Manager GRA CMC Small Molecules Development(m/w/x)
Darmstadt
Full-time, Part-timeWith Home OfficeSenior
Nejo AI Summary
You will drive global CMC strategies for innovative drug developments, bridging the gap between technical experts and regulatory bodies to ensure life-changing medicines reach patients worldwide.
Requirements
- Degree in pharmacy, chemistry, life science, or Ph.D.
- Experience in pharmaceutical industry, Health Authorities, or CMC
- Experience with NCEs or drug-linkers for ADCs
- Knowledge of global regulatory CMC requirements
- Experience driving CMC activities and authoring dossiers
- Excellent written and spoken English skills
- Passion for team collaboration and problem-solving
Tasks
- Lead global regulatory CMC activities for clinical phases and launches
- Develop global regulatory CMC and dossier strategies
- Liaise between Global Regulatory Affairs and technical functions
- Author and approve regulatory quality documents like MAA and IND
- Translate country-specific regulations into technical requirements
- Advise technical experts on analytical and drug development
- Provide strategic CMC guidance to global regulatory functions
- Participate in interdisciplinary CMC and regulatory project teams
- Lead Health Authority interactions and meetings
- Perform expert CMC assessments for licensing and due diligence
Work Experience
5 years
Education
Bachelor's degree
Languages
English – Business Fluent
Tools & Technologies
New Chemical EntitiesAntibody Drug ConjugatesCMC dossiers
Benefits
Flexible Working
- •Hybrid work format
- •Remote work possible
Career Advancement
- •Access and growth opportunities
Other Benefits
- •Workplace accessibility accommodations
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of SUSONITY 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
SUSONITY
Industry
Healthcare
Description
Das Unternehmen entwickelt Medikamente, intelligente Geräte und innovative Technologien in Therapiegebieten wie der Onkologie, Neurologie und Fruchtbarkeit.
Not a perfect match?
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