pharmalex_job_career



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.

 

Director Regulatory Informatics and Operations


Your Job

  • Subject matter expert in Regulatory Operations and related systems
  • Consult with clients and internal teams regarding Regulatory Operations, electronic submissions, and technology innovations
  • Scope, implement, maintain, and further develop global regulatory systems at PharmaLex in close collaboration with Head of Regulatory Operations, IT and other stakeholders
  • Support business development activities in the field of regulatory operations, systems, standards, and related processes
  • Support client system audits or a GxP inspections in close collaboration with the Head of Regulatory Operations and Quality Management
  • Assist in the development of customer-specific solutions and processes in cooperation with clients
  • Support the global Regulatory Operations teams in technical areas such as datasets, SPL, etc.
  • Lead and manage large and/or complex project teams
  • Contribute to the division/department strategy and goals
  • Support marketing, business development and sales activities
  • Improve and implement processes and/or tools to increase efficiency


Your Profile

  • 15+ years of experience and broad knowledge in the field of Regulatory Operations and Regulatory information and system management
  • Experience with complex Regulatory submissions including datasets, SPL
  • PMP certification and Global Regulatory Submission Management Expertise (NDA/MAA/BLA/NDS) a plus
  • Expert knowledge and experience with US Regulatory Affairs and submissions
  • Experience in defining and implementing new system strategies, standards, and related processes
  • Deep understanding of regulatory operations and technology landscape
  • Strong knowledge about IT systems and databases as well as related technologies
  • Drives solutions to complex problems impacting company success
  • Ability to define and convey strategic goals for PharmaLex Regulatory systems as well as strategic goals of partnerships with clients and stakeholders
  • Ability to lead large international and/or complex project teams
  • Ability to balance client requests and company interests
  • Strategic, analytical, and structured thinking and working



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.