(Senior) Manager Regulatory CMC (f/m/d)
PHARMALEX GMBH
Friedrichsdorf, Deutschland
vor 0 Min.

We are growing, grow with us

PharmaLex is one of the leading service providers for the pharmaceutical and medical device industry. Our expert teams provide innovative solutions to clients worldwide.

For you, this means a range of job and career development opportunities and lots of potential to continue learning and to further develop your skills.

At PharmaLex we strive to deliver exceptional results.The success of our company grows with the excellent expertise and the high motivation of our employees.

If for you, your profession is not only a job but a mission too and you enjoy working with people, then you are welcome to join us.

To strengthen our successful team, we are looking for a :

Senior) Manager Regulatory CMC (f / m / d)

  • 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)

    We offer you

  • Diversified and challenging job
  • Cooperating partnership and leeway
  • Flexible working hours based on trust
  • Possibility to work part-time
  • Possibility to work from home
  • Continuous development opportunities through knowledge and experience as well as training
  • Your Profile

  • 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
  • Highly service orientated
  • Fluency in English, spoken and written
  • Computer literacy and confidence with business applications
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