Senior Manager CMC Regulatory Affairs (gn)

Einsatzort: Planegg

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MorphoSys's mission is to make exceptional, innovative biopharmaceuticals to improve the lives of patients suffering from serious diseases. Innovative technologies and smart development strategies are central to our approach. Success is created by our people, who focus on excellence in all they do, collaborate closely across disciplines. We all are driven by a desire to make the medicines of tomorrow a reality. Guided by mutual respect and trust, each member of the MorphoSys team is given the opportunity to develop and flourish within this exciting and inspiring environment. Join us in Planegg near Munich!

We would like to fill the follow­ing vacancy as soon as possible:

Senior Manager CMC Regulatory Affairs (gn)

Your Responsibilities:

  • Management of operational RA aspects within the daily collaboration with CMOs and partners during CMC development in close coordination with the RA department and interdisciplinary project teams
  • Coordination of document compilation for late stage development activities like CQA assessment, process characterization / process validation, and control strategy establishment
  • Preparation of quality sections for BLA and MAA as well as for IMPD and IND
  • Coordination of filing activities within the CMC team and with contributing parties
  • Observation and tracking of CMC relevant regulatory interactions between MorphoSys, external partners, and regulatory agencies
  • Contribution to internal and external meetings as CMC-RA expert for GMP-relevant guidance and regulations
  • Continued observance of regulatory guidance and regulations with respect to revisions or additions

Your Requirements:

  • Degree in Life Sciences, Pharmacy, Chemical Engineering or Bioengineering
  • Proven track record in biotech or pharmaceutical industry
  • At least 5 years professional working experience in the GMP / RA environment, preferably in the development of biologics
  • Experience in state-of-the-art Regulatory Affairs related procedures in drug development for biologics
  • Experience with CMC requirements for late stage clinical development and compilation of module 3 submission packages
  • Highly motivated and open-minded team player with well-developed interpersonal abilities and a clear commitment to represent CMC-RA in interdisciplinary working groups
  • Excellent communication skills, both in English and German
  • Sound knowledge of Microsoft Office applications

We offer:

  • Creative working in X-functional teams
  • Open and respectful corporate culture
  • Multicultural environment
  • Working in an attractive, state-of-the-art building with in-house restaurant
  • Free sports and language courses

Thank you for your inter­est! We are look­ing for­ward to receiv­ing your pertinent app­lication do­cuments. For your app­lication please use ex­clusiv­ely our career por­tal www.morphosys.com/careers/job-opportunities. We offer not only excellent career prospects, but also support you from the very beginning - even helping you move if neccessary.

MorphoSys AG, Semmelweisstraße 7, 82152 Planegg