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.
We are looking for a Principal Consultant & Regulatory Information Management Lead in any location around the Globe where PharmaLex has an office.
Director, Regulatory Operations
Reports to: Head of Regulatory Operations
- Scoping, implementation, maintenance and further development of global regulatory systems at PharmaLex in close collaboration with Head of Regulatory Operations, IT and other stakeholders
- Supporting business development activities in the field of regulatory systems, standards and related processes
- Defining PharmaLex’ strategy regarding regulatory systems
- Acting as system owner and responsible person for related business activities, such as business administration, data entry, implementation activities and software validation
- Building and maintaining contacts to software vendor representatives
- Aligning regulatory system strategy with related departments from other PharmaLex divisions, such as IT, PV systems etc.
- Supporting client system audit or a GxP inspections in close collaboration with the Head of Regulatory Operations and Quality Management
- Consulting of clients regarding Regulatory system questions and innovations in cooperation with other stakeholders
- Fulfil of sophisticated tasks of high complexity
- 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 her field of expertise
- Lead large and/or complex project teams; take over the management of the overall project management
- Analyze and solve problems and develop pragmatic solutions
- Collaboration in designing the division/department strategy with the Head of the department/division as well as define strategic goals of partnerships with clients
- Provision of appropriate expertise regarding her area of expertise
- Advancements of processes and/or tools within defined area of expertise in collaboration with the Head
- 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"
- Keeping updated in area of expertise
- Technical support, guidance and coaching of team members
- Several years of experience and broad knowledge in the field of Regulatory Operations and Regulatory information and system management
- Experience in defining and implementation of new system strategies, standards and related processes
- Deep understanding of regulatory landscape, esp. in regards of systems, standards and related processes;
- Strong knowledge about IT systems and databases as well as related technologies
- Drives solutions to complex problems impacting company success
- Ideally: experience in adjacent areas of expertise or willingness to broaden the knowledge/to build up knowledge in complementary fields of expertise
- 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 and
- Ability to balance client requests and company interests
- Ability to analyse and solve problems and to develop pragmatic solutions at higher (e.g. company) level
- Excellent skills in moderating and presentation
- Strategic, analytical and structured thinking and working
- Good ability to impart knowledge and presentation skills
- Ability to lead large international and/or complex project teams, convincing team members in difficult change management situations and achieving commitment according project milestone
- Ability to manage client relationships on VP level and to convey strategic goals of collaboration
- Convincing and confident appearance, proven capability to communicate critical issues and proposed solutions to senior management levels; ability to convey stakeholders even in critical or sensitive situations
- Ability to adjust rapidly to new, unknown, challenging situations
- Full discretion to drive strategy and take actions consistent with operating policies
- English language business fluency
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
- salary expectations
- Your CV in English language!
Agencies only by prior agreement for the specific job opportunity.