We are seeking a talented and motivated Scientific intern/working student regulatory affairs (m/f/d) to contribute to apply, test, characterize Open Systems Pharmacology PBPK platform in light of regulatory requirements.

ESQlabs is an innovative, internationally acting Contract Research Organization and a global leader in the development and application of the OSP Suite (www.open-systems-pharmacology.org). We are a research-focused provider of specialized computational analyses in the life sciences industry.

Recently, EMA filed a qualification opinion for a commercial PBPK platform and further work is needed to assess feasibility, outline the scope, identify gaps and plan / start additional work on the qualification package for OSP.

To help us with that task and to generally  enhance regulatory acceptance of Open Systems Pharmacology (OSP) platform, we are looking for a motivated and detail-oriented intern or working student with a strong interest in regulatory aspects to strengthen our team.

Role

Your primary responsibility is to support qualification documentation and future formal regulatory qualification processes for the OSP. You will contribute to the preparation, coordination and documentation required for interactions with stakeholders including regulatory scientists and health authorities. Tasks include:

• Map the EMA qualification procedure and define requirements to assess the feasibility of conducting an EMA qualification process for OSP.

• Compile and organize existing submission-relevant documentation, performing gap analyses against the existing OSP (re)qualification framework.

• Support the preparation and drafting of documents that can help with future EMA qualification submissions.

• Conduct quality checks on documents and PBPK models to ensure clarity, accuracy, and compliance with regulatory standards.

• Collaborate closely with internal stakeholders to ensure alignment on regulatory strategy and submission readiness.
  
  

Required skills & experience

• Currently pursuing or already holding a Master’s degree or PhD in pharmacokinetics, clinical pharmacology, regulatory sciences, or a related discipline.

• Experience with mechanistic physiologically based pharmacokinetic (PBPK) modeling and simulation; proficiency with modeling tools such as OSP Suite (PK-Sim, MoBi) and R is highly desirable.

• Strong written and verbal communication skills, with the ability to convey complex scientific and regulatory concepts clearly.

• Highly organized, proactive, and comfortable managing tasks independently in a fully remote environment.

• Excellent critical-thinking and problem-solving abilities, with a commitment to high-quality output.

• Exceptional attention to detail and accuracy in documentation.

• Fluent written and spoken English skills; German proficiency is a plus.
  

 Further qualities that will put you in the spotlight

• Understanding of EMA qualification procedures, regulatory submissions, or scientific advice processes.

• Experience working with GitHub for version control and collaborative documentation.

• Knowlegde of the OSP reporting enguine and (re)qualification framework.

What's in store for you
The dynamic team behind ESQlabs unites people with different backgrounds, spanning disciplines like pharmaceutical sciences, physics, bioinformatics, mathematics, data science, and software engineering. Our trust in each other, our open-mindedness, and our constant quest for excellence and innovation unite us. We value flat hierarchies, where everyone can contribute ideas and expertise to develop the best product. We are passionate, always willing to broaden our horizons, and love our start-up culture.

You will also benefit from:

• Flexible work hours and a home office policy that focuses on people and not on numbers

• A working environment in which your contribution will make a difference, and that allows you to take ownership of projects and processes

• Responsibility, autonomy, participation, and career perspective

About us

We collaborate with global corporations in the pharma and chemical industry, as well as start-ups in the life-science technology sector and academic and non-profit research institutions. We define new standards in pharmacometrics and systems pharmacology and toxicology areas. Our software and model platforms help scientists understand mechanisms of diseases and chemical toxicity to optimize individualized treatment of patients and protect the health of the animal and human life.

ESQlabs has attracted international players as sponsors for the OSP Software development. In addition, funding through national and EU-wide research grants allows us to develop our core technologies continuously.

For more information about our culture, values and benefits visit our Unique career opportunities - ESQlabs GmbH.

At ESQlabs, we are committed to diverse backgrounds and experiences.