Beschreibung
Aktuell bin ich für einen unserer Kunden auf der Suche nach einem Regulatory Affairs / CMC - Experten auf Interim-Basis.Responsibilities:
- Compile and check pharmaceutical quality documentation (Module 3, QOS, IMPD, ASMF etc.) for national and international markets
- Prepare Gap Analyses of pharmaceutical quality dossiers in the context of marketing authorization projects, Due Diligence
- Set up responses to deficiency letters from authorities
- Supervise development projects and marketing authorization procedures with regard to the pharmaceutical quality documentation
- Compile and review Product Quality Reviews (PQRs)
- Coordinate and perform CEP procedures
- Coordinate and perform Life Cycle Management processes with regard to the pharmaceutical quality documentation (change control procedures, prepare and submit variations, site transfers etc. with regard to strategy and content)
Requirements:
- Degree in natural sciences (preferably pharmacy, chemistry or biology)
- Experience in Pharmaceutical Quality with a focus on regulatory aspects of the pharmaceutical quality documentation
- Practical experience in regulatory submissions (MAA, CTA, CEP, Life Cycle Management processes etc.) and in Regulatory Compliance
- German / English
Details:
- Start: ASAP (1.7.15)
- Duration: 6+ Months
- Volume: 80% - 100%
- Location: on site, Rhein-Main + remote
Für mehr Informationen über Progressive Recruitment, besuchen Sie www.progressiverecruitment.com