Immatics N.V.
Associate Director Regulatory Affairs – CMC Lead(m/w/x)
Full-timeWith HomeofficeManagement
München
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FOFormycon AG
Team Lead Regulatory CMC Drug Product(m/w/x)
Planegg
Full-timeWith Home OfficeSenior
Nejo AI Summary
Aligning RegCMC DP strategy for biopharmaceutical development and approved products, focusing on drug-device combination products. Minimum 6 years of Regulatory CMC experience with parenteral products required. 30 days vacation, additional days off, and employer-supported pension.
Requirements
- Scientific background with master's degree or PhD
- Master's degree or PhD in biology, chemistry, biochemistry, pharmacy or equivalent
- Minimum 6 years experience in Regulatory CMC
- Experience with parenteral products
- Experience with drug-device combination products
- Thorough knowledge of drug development process
- Experience in multiple development phases up to submission
- Excellent staff leadership skills
- Excellent communication skills
- Fluency in written and spoken English
- Very good team player
- Result oriented
- Persistent
- Well organized
- Proactive
- Problem solver
- Able to work independently
- German work permit mandatory
Tasks
- Align RegCMC DP strategy for development projects and approved products
- Review and align strategy for essential concepts with focus on DP aspects
- Ensure timely preparation and review of regulatory documents
- Establish strategies for drug-device combination products
- Liaise with clinical department for human factor studies
- Oversee documentation package preparation and submission to Notified Bodies
- Coordinate design history file establishment and maintenance
- Guide RegCMC Drug Product team in submission strategies
- Support response strategies for authority requests
- Maintain knowledge of global regulatory landscape
- Participate in meetings with regulatory agencies
- Manage team capacity allocation
- Coordinate regulatory CROs for assigned work packages
- Compile and maintain budget and capacity plans
Work Experience
- 6 years
Education
- Master's degree
Languages
- English – Business Fluent
Benefits
More Vacation Days
- 30 days of vacation
- Additional days off
Additional Allowances
- Formycon Mastercard
- Participation in international conferences
Retirement Plans
- Employer-supported pension scheme
Healthcare & Fitness
- Comprehensive health & wellbeing offering
Other Benefits
- Occupational health services
- Group accident insurance
- Diversity focus
- Equal opportunity
Corporate Discounts
- Fitness discounts
Mental Health Support
- Mental health support
Career Advancement
- Individual development and career paths
Learning & Development
- Internal trainings
- Participation in scientific events
Informal Culture
- Collaborative culture
- Inclusive culture
- Respectful environment
Modern Office
- Modern working environment
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Formycon AG 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.
Not a perfect match?
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FOFormycon AG
Team Lead Regulatory CMC Drug Product(m/w/x)
Planegg
Full-timeWith Home OfficeSenior
Nejo AI Summary
Aligning RegCMC DP strategy for biopharmaceutical development and approved products, focusing on drug-device combination products. Minimum 6 years of Regulatory CMC experience with parenteral products required. 30 days vacation, additional days off, and employer-supported pension.
Requirements
- Scientific background with master's degree or PhD
- Master's degree or PhD in biology, chemistry, biochemistry, pharmacy or equivalent
- Minimum 6 years experience in Regulatory CMC
- Experience with parenteral products
- Experience with drug-device combination products
- Thorough knowledge of drug development process
- Experience in multiple development phases up to submission
- Excellent staff leadership skills
- Excellent communication skills
- Fluency in written and spoken English
- Very good team player
- Result oriented
- Persistent
- Well organized
- Proactive
- Problem solver
- Able to work independently
- German work permit mandatory
Tasks
- Align RegCMC DP strategy for development projects and approved products
- Review and align strategy for essential concepts with focus on DP aspects
- Ensure timely preparation and review of regulatory documents
- Establish strategies for drug-device combination products
- Liaise with clinical department for human factor studies
- Oversee documentation package preparation and submission to Notified Bodies
- Coordinate design history file establishment and maintenance
- Guide RegCMC Drug Product team in submission strategies
- Support response strategies for authority requests
- Maintain knowledge of global regulatory landscape
- Participate in meetings with regulatory agencies
- Manage team capacity allocation
- Coordinate regulatory CROs for assigned work packages
- Compile and maintain budget and capacity plans
Work Experience
- 6 years
Education
- Master's degree
Languages
- English – Business Fluent
Benefits
More Vacation Days
- 30 days of vacation
- Additional days off
Additional Allowances
- Formycon Mastercard
- Participation in international conferences
Retirement Plans
- Employer-supported pension scheme
Healthcare & Fitness
- Comprehensive health & wellbeing offering
Other Benefits
- Occupational health services
- Group accident insurance
- Diversity focus
- Equal opportunity
Corporate Discounts
- Fitness discounts
Mental Health Support
- Mental health support
Career Advancement
- Individual development and career paths
Learning & Development
- Internal trainings
- Participation in scientific events
Informal Culture
- Collaborative culture
- Inclusive culture
- Respectful environment
Modern Office
- Modern working environment
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Formycon AG 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
Formycon AG
Industry
Pharmaceuticals
Description
Formycon is a leading developer of biopharmaceutical medicines, especially biosimilars, spanning the entire value chain from development to regulatory approval.
Not a perfect match?
- Immatics N.V.
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