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Regulatory Documentation Specialist CMO - Purchasing Department (m/f/d) - Job Berlin - Karriere: ESTEVE

Regulatory Documentation Specialist CMO - Purchasing Department (m/f/d)

Advancing in innovation to improve people's lives has been our mission since our establishment in 1929. We are a global pharmaceutical company, headquartered in Barcelona, with pharmaceutical affiliates in Spain, Germany, France & the UK, and with state-of-the-art industrial sites in Mexico and China to serve our CMO business worldwide. This pharmaceutical and CMO platform allows us to continue to serve the medical needs of patients with passion and commitment.

We take pride in our values and reflect them in everything we do: people matter, transparency and accountability. Because this is the only way we know how to do business and because, as a healthcare company, we have a huge responsibility to both people and the environment.

With immediate effect we are looking for support in the Pharma Direct Procurement department in Berlin as  a Regulatory Documentation Specialist (m/f/d) 

Roles and Activities

Collaborating with the coordination and monitoring of the required documentation:

  • Attending the projects meetings for collaborating with the coordination of the internal activities related to the CMC (DS-Drug Substance and DP-Drug Product) at development stage, registration and commercial stage (LCM)
  • Selection of alternative sources for FDFs and API: Managing/handling of documentation (Legal and Quality)
  • Product guard: Collaborating in the activities related to the project management along with the Quality and CMO Management dept., with the designing of the documentation management system, as well as with the documentation management itself (Technical, Legal and Quality wise)

Contribution:

  •  Managing/handling and negotiating a specific and reduced CMOs portfolio through annual forecasts, contracts review, as well as initiating and participating in the screening, tenders and awarding of contracts during the introduction of new sources (FDFs and APIs)
  • Collecting the information (know-how, technical, quality and regulatory requirements, etc) of FDFs and APIs for the projects related to the pharma portfolio, either at commercial or development stage, in order to align in a correct manner the CMC’s activities with the targets of the Esteve’s R&D projects
  • Collaborating with CMO Management and Quality team in obtaining the information generated by the CMOs, in a way that the same meets the regulatory requirements of key territories during the commercial and development stage of Esteve’s products
  • Assuring the harmonization of the Pharma Management (systems and business wise) with the rest of the Esteve Group, through the cooperation and participation, matrix wise, with the Global Direct Procurement Compliance and Regulatory Manager

Requirements for the position

Required:

  • Bachelor in Life Science or a comparable professional degree
  • 3-5 year experience in subcontracting services CMC to CMOs
  • Experience dealing with CMOs about Regulatory Affairs, QA and QC issues
  • 3-5 year experience in the Pharmaceutical Industry in an international environment
  • Experience working in a matrix system organization
  • English (as per CEFR): C1/C2
Valuable:
  • Knowledge in Regulatory Affairs, Quality (GMPs) and Documentation Management
  • Medicine Supply
  • Experience in documentation Management, Opentext, Sharedrives or other comparable systems
  • SAP knowledge is an advantage

Our Offer

  • Permanent job in an international pharmaceutical environment with flexible working hours and the possibility of home office
  • Employer's contribution to the company pension scheme through deferred compensation
  • Allowance for lunch, as well as a free beverage offer
  • BVG job ticket
  • Very good transport connections
  • Interesting and challenging field of activity
Submit application

WIR sind ESTEVE

ESTEVE ist ein weltweit tätiges Spezialpharmaunternehmen mit mehr als 90 Jahren Erfahrung und pharmazeutischen Niederlassungen in Spanien, Deutschland, Frankreich und Großbritannien.

Außerdem verfügt es über hochmoderne Industriestandorte in Mexiko und China, um das CMO-Geschäft abzudecken. Die pharmazeutischen und CMO-Plattformen ermöglichen es ESTEVE, weiterhin mit Leidenschaft und Engagement den ungedeckten medizinischen Bedarf der Patienten zu bedienen.

Innovationen voranzutreiben, um das Leben der Menschen zu verbessern, ist die Mission von ESTEVE seit seiner Gründung.

International aufgestellt, aber nicht abgehoben. Professionell geführt, aber nicht festgefahren.

Bewegen Sie sich - und uns

Bei ESTEVE können Sie etwas bewegen, ohne gegen Konzernstrukturen ankämpfen zu müssen.

Ideen und Unternehmertum werden bei uns groß geschrieben, denn wir wollen als Unternehmen genauso wenig stehen bleiben wie unsere Mitarbeiterinnen und Mitarbeiter.

Bewegen Sie sich mit UNS!

Was Sie bei ESTEVE erwartet

Durch flache Hierarchien, modern ausgestattete Arbeitsplätze und kurze Entscheidungswege geben wir Ihnen Gestaltungsfreiraum für Ihre Ideen. 

Ein verantwortungsvolles und anspruchsvolles Aufgabengebiet in einem internationalen Arbeitsumfeld wartet auf Sie. Wir fordern und fördern unsere Mitarbeiter gezielt und aktiv. 

Überzeugen Sie sich selbst!