Beschreibung
Technical Drug Regulatory Affairs Manager (m/f/d)
Reference: -en
Start: asap
Duration: 36 MM
Main tasks:
- Represent the technical regulatory function on cross-functional teams with respect to Drug- and Device Combination Product
- Provide strategic leadership and regulatory guidance to the teams/functions on technical regulatory Drug- and Device Combination Product issues
- Successfully negotiate technical regulatory plans
- Manage the generation of high quality global regulatory submissions for clinical trials and marketing authorization applications in collaboration with the other disciplines
Main qualifications
- University degree (Master or PhD) in a scientific discipline
- Profound industry experience in regulatory as well as Drug- and Device combination Product
- Excellent communication, collaboration, and interpersonal skills
- Effective problem solving and strong organizational skills, including ability to prioritize tasks
- Pro-active working style
- Experience in working in cross-functional teams and across time zones
- Apart from your proven Regulatory CMC experience with regards to preparation of regulatory applications and submissions, planning of regulatory strategies, assessing regulatory compliance and supporting quality systems, knowledge in Biotechnology as well as Drug- and Device combination product experience is required
Main advantages:
- A city with a high quality of life that perfectly embraces both modern and traditional values
- A highly motivated team and an open way of communication
- You will work in an international environment
- Good infrastructure
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:
Angela Ramona Weishaar
Referencenumber:
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