Senior Regulatory Affairs & CMC Manager - Biologics (m/f/d)

at  Hays

München, Bayern, Germany - 00000

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate20 Oct, 2019Not Specified20 Jul, 201915 year(s) or aboveWorking Experience,Compilation,Pharmaceutical Industry,Bioengineering,Drug Development,Communication Skills,Life Sciences,Chemical Engineering,Regulatory Affairs,Clinical Development,BiologicsNoNo
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Description:

My duties

  • Management of operational RA aspects within the daily collaboration with CMOs and partners during CMC development in close coordination with the RA department
  • 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 customer, 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

My qualifications

  • Degree in Life Sciences, Pharmacy, Chemical Engineering or Bioengineering
  • Proven track record in biotech or pharmaceutical industry
  • Profound 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
  • Excellent communication skills both in English and German
  • Sound knowledge of Microsoft Office applications

My benefits

  • Creative work in X-functional teams
  • Open and appreciative corporate culture
  • Multicultural environment
  • Working in an attractive, well-equipped building with a staff restaurant
  • Free sports and language courses

My employer

  • Our client is a very successful company and a global player in a number of industries. Due to its flat hierarchies and lean structures, our client offers significant potential for further development.
  • Attractive compensation package

About Hays
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
My contact at Hays

Responsibilities:

  • Management of operational RA aspects within the daily collaboration with CMOs and partners during CMC development in close coordination with the RA department
  • 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 customer, 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 addition


REQUIREMENT SUMMARY

Min:15.0Max:20.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Clinical Pharmacy

Graduate

Chemical, Engineering

Proficient

1

München, Germany