Description
Senior Technical Regulatory Manager CMC (m/f)
Reference: -en
Start: asap
Duration: 6 MM+
Main tasks:
- Authoring of high quality global marketing applications (NDA/MAA)
- Facilitation of review of dossier including adjudication meetings
- Prepare high quality internal analytical reports
- Participate in cross-functional project teams and work effectively with multiple disciplines and personalities
- Compliance check of internal reports with raw data and regulatory dossier with internal reports
Main qualifications
- University degree (preferably Master or PhD) or equivalent in chemistry, pharmacy or relevant engineering discipline
- Experience in small molecules CMC Regulatory or in pharmaceutical development activities (then combined with a strong understanding of regulatory affairs)
- Recent knowledge and experience of health authorities CMC requirements for small molecules products marketing authorization applications is of solid advantage
- Direct experiences with current regulatory trends (examples Quality by Design, genotoxic impurities, starting material selection) are a plus
- Good project leadership skills and experience, including working cross– functionally and cross-disciplines
- Strong prioritization skills, able to work calmly under pressure, happy to work both collaboratively and independently, track record in effective problem solving
- Outstanding interpersonal skills, fluent in English; German is an advantage; direct experiences with working across cultural areas in a global environment is a plus
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.
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