We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.
Head of Global Regulatory CMC
- Build and maintain a cross-functional organization supporting large and/or international projects /programs or services thereby capitalizing PLX’s international structure
- Development of the service areas and product portfolio together with the Global Head of VDC REG and other Serivce Area / VDC Heads, based on the overall service strategy set by the CSO
- Oversee Service Area`s operations and support capacity planning/assignment to ensure production efficiency, quality, timelines, budget, and cost-effective management of resources
- Controlling of relevant VDC figures / budgets / projects and discuss results with CEO/Country managers
- Expand the geographic footprint of the service offering
- Global proposal management in alignment with International Service Coordinators; support Cross VDC/REG proposal management
- Interface to global and local sales organization (incl. sales trainings)
- Core business development and campaigns for Regulatory CMC services and product portfolio management together with the VDC Board to advance the VDC’s objectives and to promote its growth.
- Development of adequate standards, processes, SOPs/WIs and workflows for standard business processes as part of the overall Regulatory Quality Management System
- Maintenance of standard proposal text modules for Reg CMC services in Explore
- Regulatory CMC Intelligence and training offerings
- Clarification of roles and responsibilities within the Service Area
- Provide hiring strategy and staffing as well as people development to Head of VDC Gobal Regulatory Affairs
- Ensure transfer of knowledge within the Regulatory CMC area
- Resolution of Regulatory CMC internal conflicts
- Transfer of Inter- Regulatory CMC conflicts to Head of Global Regulatory Affairs
- Build, develop and maintain working relationships with key customers
- Ensure that relevant data is presented to the Head of Global Regulatory Affairs
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
Agencies only by prior agreement for the specific job opportunity.