Senior Regulatory Manager
ProClinical is seeking a Senior Regulatory Manger for a life science consultancy company to be based in South Germany on a permanent basis.
- Compile and check pharmaceutical quality documentation (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)
Skills and 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
- Experience in biologicals and biosimilars
- Independence, flexibility and motivation
- Excellent communication skills, team spirit and social competence
- High sense of responsibility and self-motivation
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Tanja Ruschenschmidt on or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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