KI-Beschreibung

In this role, you will be at the forefront of generating and analyzing critical data for medical devices, ensuring compliance with regulations, and leading innovative projects. Your daily responsibilities will include testing, documentation, and collaboration with project teams to enhance product quality.

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  Apprenticeship or secondary school, or bachelor's or master's degree in Technical/
  Engineering/
  Life-Sciences
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  Environment, experiments design, health and safety (EHS), laboratory equipment, manufacturing process, materials science, process simulation, SOP (Standard Operating Procedure), technical writing, Waterfall model

Deine Vorteile

KI-Beschreibung

In this role, you will be at the forefront of shaping global CMC regulatory strategies for innovative projects. Your day-to-day responsibilities will involve leading submission activities, ensuring compliance, and collaborating with cross-functional teams to drive successful interactions with Health Authorities.

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  Minimum 8 years regulatory experience or pharmaceutical industry experience
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  Substantial knowledge in regulatory submission and approval processes
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  Science degree or equivalent

Deine Vorteile

KI-Beschreibung

You manage and coordinate extractables and leachables projects, conducting studies and analyses while ensuring compliance with regulatory standards and promoting collaboration across teams.

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  8+ years of working experience
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  Expertise in analytical technologies
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  University degree in relevant science discipline

Deine Vorteile

KI-Beschreibung

You manage global CMC regulatory strategies and submissions, ensuring compliance and quality documentation while effectively communicating risks and coordinating with stakeholders throughout project lifecycles.

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  Minimum 5 years of regulatory CMC experience
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  Knowledge in regulatory submission processes
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  Proven ability to evaluate scientific data

Deine Vorteile

KI-Beschreibung

You will develop and implement global regulatory strategies for CMC, manage submission activities, and ensure compliance while collaborating with cross-functional teams and engaging with health authorities.

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  Minimum 8 years regulatory experience preferred
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  Substantial knowledge in regulatory submission
• •
  Proven ability to evaluate scientific data

Deine Vorteile

KI-Beschreibung

As a Senior Manager in RA CMC, you will shape global regulatory strategies and oversee submission activities, ensuring compliance while driving innovation. This role involves collaborating with teams, managing risks, and engaging with Health Authorities to support product development.

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  Minimum 5 years of regulatory CMC experience or pharmaceutical industry experience
• •
  Knowledge in regulatory submission and approval processes
• •
  Science degree or equivalent

Deine Vorteile

KI-Beschreibung

In this role, you will lead E&L project activities, applying scientific expertise to manage studies and collaborate with internal labs and external partners. Your work will involve designing protocols, interpreting results, and ensuring compliance with evolving regulations.

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  University degree (preferably PhD) in Pharmacy, Polymer or Food Chemistry, Life Sciences or relevant science discipline
• •
  8+ years of working experience in pharma/
  biopharmaceutical industry or relevant industry
• •
  Expertise in analytical technologies: Headspace-GC/
  MS, LI-GC/
  (HR)MS, HPLC/
  (HR)MS, and related sample preparation techniques

Deine Vorteile

KI-Beschreibung

In this role, you will actively support the development of innovative drug candidates by conducting experiments and analyzing data. You will also document your findings and collaborate with the team to enhance processes, gaining valuable insights into drug substance development.

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  Enrollment in a Master’s program in life science
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  Interest or knowledge in data science, statistical data analysis, process modeling, simulation, automation, and basic programming
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  Advanced communication skills in English

KI-Beschreibung

In this role, you will actively support the development of innovative drug candidates by conducting experiments and analyzing data. You will also collaborate with a dedicated team, documenting findings and presenting them to enhance drug substance processes.

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  Enrollment in a Master’s program in life science
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  Interest or knowledge in data science, statistical data analysis, process modeling, simulation, automation, and basic programming
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  Advanced communication skills in English

KI-Beschreibung

You lead scientific strategies and oversee technical activities in drug product development, ensuring timely delivery and compliance with quality standards while mentoring junior team members.

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  2-5 years in biotech/
  pharmaceutical industry
• •
  PhD or Master in relevant discipline
• •
  Solid understanding of quality standards

Deine Vorteile

KI-Beschreibung

You manage global CMC regulatory strategies and submissions, ensuring compliance and effective communication with stakeholders while leading interactions with health authorities.

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  At least 2 years’ regulatory CMC experience
• •
  Science degree or equivalent
• •
  Working knowledge of chemistry/
  biotechnology

Deine Vorteile

KI-Beschreibung

In this role, you will drive global CMC regulatory strategies and oversee submission activities, ensuring compliance and quality throughout the product lifecycle. Your expertise will guide interactions with health authorities and support project teams in navigating regulatory challenges.

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  Science degree or equivalent; advanced degree desired
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  At least 2 years’ experience in regulatory CMC or pharmaceutical industry
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  Working knowledge of regulations, guidelines, and product life cycle maintenance

Deine Vorteile

KI-Beschreibung

You conduct human factors studies and user research, collaborating with various teams to translate user needs into design requirements while providing actionable insights to support regulatory submissions.

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  3+ years of experience in human factors engineering
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  MSc in relevant engineering or sciences
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  Strong understanding of usability engineering standards

KI-Beschreibung

You oversee quality assurance for Data and Digital projects, ensuring compliance and effective execution. Your role involves leading initiatives, promoting the use of AI, and maintaining communication across teams to enhance quality processes.

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  5+ years of relevant experience
• •
  Demonstrated experience in project management
• •
  Strong quality background

Deine Vorteile

KI-Beschreibung

You oversee quality assurance for Data and Digital projects, ensuring compliance and effective execution. Your role involves leading initiatives, promoting the use of AI, and maintaining regulatory standards while collaborating with various teams.

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  5+ years of relevant experience
• •
  Demonstrated experience in project management
• •
  Strong quality background

Deine Vorteile

KI-Beschreibung

You manage quality assurance and compliance initiatives, ensuring adherence to regulations and fostering continuous improvement in clinical programs while addressing quality issues and supporting corrective actions.

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  Functional breadth
• •
  Critical negotiations
• •
  Project management

Deine Vorteile

KI-Beschreibung

You manage quality assurance tasks, ensuring compliance with regulations and supporting initiatives to improve quality performance across clinical programs and operational activities.

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  Functional breadth
• •
  Critical negotiations
• •
  Project management

Deine Vorteile

KI-Beschreibung

You lead the ITOT team, ensuring project delivery and operational support while collaborating with various stakeholders. Your role includes managing the budget, overseeing compliance, and maintaining high system reliability.

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  Minimum of 7 years in Automation or IT
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  In-depth knowledge of automation systems
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  Bachelor's degree in Computer Science

Deine Vorteile

KI-Beschreibung

You will design and develop system solutions for the R&D Lab, ensuring timely project delivery and adherence to security policies while leading cross-functional teams and resolving application issues.

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  Expert technical understanding of Lab Applications
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  Several years of experience in Pharma or IT
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  Expert knowledge of GXP and 21CFR Part 11

KI-Beschreibung

You will design and develop system solutions for the R&D Lab, lead project delivery, troubleshoot application issues, and ensure compliance with security policies while collaborating with cross-functional teams.

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  Expert technical understanding of Lab Applications
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  Several years of experience in Pharma or IT
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  Expert understanding of Lab business processes