Senior Developer Pharma
vor 2 Wochen
Senior Developer Pharma
Location:
Aachen, Germany
Working Hours:
32–40 hours/week (part-time or full-time)
Start Date:
As soon as possible
Employment Type:
Permanent position
O11 biomedical
is a highly innovative and dynamic start-up based in Aachen, Germany. We are developing a groundbreaking medicinal product for the treatment of
COPD (Chronic Obstructive Pulmonary Disease)
— offering a novel therapeutic approach in respiratory medicine.
To strengthen our team, we are looking for an experienced and driven:
Senior Developer Pharma for our product RESPILIQ
TM
Your Role:
As senior developer, you will oversee and coordinate all regulatory activities for the authorization of our lead product, RESPILIQ. You will play a key strategic and operational role across three core areas:
- Clinical Development
- Quality Management / Quality Assurance (QM/QS)
- GMP-compliant Manufacturing
In this role, you will:
- Lead and manage cross-functional regulatory processes
- Act as the key liaison with regulatory authorities and external partners (e.g., CDMOs, CROs)
- Provide strategic input to senior management
- Support hands-on implementation of regulatory requirements in the company
Your Profile:
- Minimum
10 years of broad experience
in pharmaceutical regulatory affairs - Strong expertise, preferably in Clinical development, alternatively in GMP manufacturing or QM/QS
- Excellent knowledge of European and national regulatory frameworks
- Structured, solution-oriented mindset and hands-on approach
- Strong communication and leadership skills
- Fluent in
German and English
, both written and spoken
What We Offer:
- A
key leadership position
in an innovative and growing biotech start-up - High-impact work in a professional, collaborative, and forward-thinking team
- Attractive salary
and permanent employment - Excellent working conditions at our office in the heart of Aachen
- Flexible working hours (32–40 hours/week)
Join O11 biomedical and help shape the future of COPD treatment.
We look forward to receiving your application
Apply now:
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