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.


Senior Manager Regulatory Information Management

Your Job

  • Develop and support strategies for software solutions in the area of Regulatory Affairs and related fields
  • Planning, preparation, execution, and management of large and cross-functional projects in the context of RIM
  • Prepare and execute consulting projects with clients in the field of RIM, incl. preparation of corresponding proposals and business development material
  • Understand, define, and document system and user requirements for existing and future Regulatory systems
  • Develop test and validation strategies for electronic systems according to Computer System Validation standards
  • Prepare and provide internal and external trainings for Regulatory systems
  • Align RIM activities with related areas and act as interface to IT and other stakeholders as well as software vendors
  • Support the system owner and responsible persons for related business activities, such as business administration, data entry, implementation activities, and software validation
  • Development of customer-specific solutions and processes in cooperation with clients
  • Build, develop and maintain working relationships with clients
  • Accountability for competent advisory service in their field of expertise
  • Mentoring of employees within the department/the division/the company within departmental/divisional field of activity
  • Gathering and sharing of experiences regarding area of expertise with focus on experience exchange, "Lessons Learned" and "Best Practice"

Your Profile

  • Several years of experience and broad knowledge in the field of Regulatory Operations and Regulatory information and system management
  • Deep understanding of regulatory landscape, esp. in regards of systems, standards and related processes
  • Profound knowledge about IT systems and databases as well as related technologies
  • Ability to analyse and solve problems and to develop pragmatic solutions at higher (e.g. company) level
  • Ideally: experience in adjacent areas of expertise or willingness to broaden the knowledge/to build up knowledge in complementary fields of expertise
    ·         Ability to lead global project teams
    ·         Ability to balance client requests and company interests
    ·         Good skills in moderating and presentation
    ·         Ability to manage client relationships and to convey strategic goals of collaboration
    ·         Convincing and confident appearance, proven capability to communicate issues and proposed solutions to management levels; ability to convey stakeholders
    ·         Ability to adjust rapidly to new, unknown, challenging situations
    ·         Full discretion to drive strategy and take actions consistent with operating policies
  • Very good written and oral English skills

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.