Beschreibung
Regulatory CMC Author (Interim) (m/f)
Reference: -en
Start: asap
Duration: 5 MM++
Main tasks:
- You are able to assess CMC related documentation and translate it into a dossier suitable for a smooth authority submission and assessment process.
- You can interpret authority feedback in a way to define potential missing data and author responses during a deficiency process or life-cycle/variation process.
- You work and collaborate with our CMC Leads in a dynamic team
- You ensure effective communication with external CDMOs and internal partners (CMC Leads and RA)
- You are strongly able to align CMC strategies for our products with the RA department
Main qualifications
- Natural science/scientific background (HTL, FH, university)
- Practical experience in CMC development of oral solid dosage forms or parenteral products (injectables, lyo) – formulation, manufacturing, analytics
- Profound knowledge of GMP and CMC regulations/guidelines
- Experience in writing / reviewing IMPDs and CTDs (Module 3)
- Strong communication and presentation skills in English and German
- IT skills (MS Office, Adobe Acrobat, alternatively MS-Project)
Main advantages:
- A very renowned company
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
My contact at Hays:
My contact person:
Anna-Elisa Hochreiter
Referencenumber:
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