Senior Expert CMC Writing (m/f/x) | Ulm / remote | Pharma
For a very innovative quantum technology startup, which is supported by leading investors from Silicon Valley and Europe to become a driving force in medical imaging, I am looking for an expert in CMC writing to develop and implement a global RA strategy, write and review regulatory documents and contribute regulatory due diligence of preclinical and early clinical data. Experience with sterile injectables needed!
If you are interested in experiencing this at a very well-positioned and innovative quantum technology startup, then you have come to the right place!
What will your activities as Senior Expert CMC Writing involve?
Develop and implement global regulatory strategies for sterile pharmaceutical products, including proactive identification of regulatory risks / options and mitigation strategies
Write and review of regulatory documents required for filing of IND/CTAs; including but not limited to CMC Modules, Product Information, responses to the Health Authority questions, clinical study protocols and reports, investigator's brochures, case report forms, informed consent forms and other relevant documents
Prepare and review briefing documents for Health Authority meetings
Contribute to regulatory due diligence of the preclinical and early clinical data in support of early development projects
Support development of Target Product Profile for assigned development projects
Monitor changes in the regulatory environments and advise on company adaptive responses
What does this position offer you?
Salary: very attractive salary package
Contract type: unlimited
Vacation: 30 days / year
Working time: 40 hours / week
Accessibility: Very good transport connections by public transport; sufficient parking spaces available
Start date: At the next possible date
Location: On-site in Ulm or up to 80% remote with ad-hoc travelling to Ulm
What requirements should you bring along?
Ph.D. or master's degree in Pharmacy, Chemistry, Biochemistry, Biology, Biotechnology or comparable
At least 8 years' experience in a hands-on Regulatory affairs CMC position for pharmaceutical drugs
5 years' experience in an early-stage development environment
Experience with QA methods / documentation
Experience in Working with IND submissions to the FDA
Experience in Working with sterile injectables
Excellent written and verbal communication skills in English & excellent communication and presentation skills
Very good comprehension, independent way of working, intercultural competence
Information about our customer:
Our client is an innovative quantum technology startup that was founded as a spin-off from Ulm University and is supported by leading investors from Silicon Valley and Europe. Their mission is to use their unique know-how in the field of quantum technology to become a driving force in the development and commercialization of novel methods of medical imaging. They are planning to almost double their size of employees over the next year (from 30 to over 50).
Does this position sound interesting to you? Then you should apply now! If you would like to receive further or alternative positions, I would also be pleased to receive your application!
I look forward to your application!