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Manager Regulatory CMC (m/f) – english - Germany  

PHARMALEX (company)


Posted on : 22 March 2017

Project Description

  • 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

Your 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)

Your qualifications
  • 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.