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Manager Regulatory CMC (m/f) english Friedrichsdorf Germany, Mannheim Germany,
Posted on : 22 March 2017
- Are you eager to work with industry experts that continue to provide new solutions to satisfy our customers?
- Are you looking for challenging projects on an international level?
- Then make our company your career choice!
- Our company is the leading service provider for the worldwide pharmaceutical industry in regulatory affairs, pharmacological and development consulting.
- We are specialized in effectively designing all aspects of drug and medicinal product registrations ranging from early development and market entry to product maintenance activities.
- We are looking for motivated, committed candidates who will enjoy working independently within our successful team in a challenging environment and continually develop our company.
- So, if your career is not only your job, but also your passion, then come and join us.
Manager (m/f) Regulatory CMC
- 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)
- 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
- Independence, flexibility and motivation
- Excellent communication skills, team spirit and social competence
- High sense of responsibility and self-motivation
- Highly service orientated
- Fluency in English, spoken and written
- Computer literacy and confidence with business applications
We offer you
Exciting and varied challenges in a friendly team, contact and interaction with nearly all branches of the company, as well as many opportunities for personal development and job training.
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