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At ESTEVE we are firmly committed to people. One of the hallmarks of our corporate culture is our pledge to develop human capital.
Collaboration and teamwork are part of our operating principles, and we promote an attitude among our employees that is proactive, critical and, at the same time, constructive. Acceptance of responsibilities, action-oriented and accountability are necessary attributes to be part of our team.
As a result, we are mindful of the setting in which our employees do their work. One of our priorities is to maintain a good working environment and to improve working conditions every day by applying measures to balance work and personal life and prevent occupational hazards, and by providing benefits to our employees.
RIEMSER is part of ESTEVE.
With immediate effect we are looking for support in the Pharma Direct Procurement department in Berlin as Pharma Direct Procurement Compliance & Regulatory 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
Weitere Informationen
Hohenzollerndamm 151
14199 Berlin
