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 Systems and Data Management
- Consulting of clients regarding Regulatory Operations, electronic submissions, and technology innovations regarding his/her area of expertise
- 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
- 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
- Development of customer-specific solutions and processes in cooperation with clients
- Deputising for the Chair of the Regulatory Governance Board as required
- Managing the Regulatory Governance Board meetings and ensuring compliance with corresponding SOP
- Regular communication with Domain Experts to discuss operational, process, quality and system issues
- Develops Business Cases for new systems or updates to existing
- Prioritises systems activities across domains and makes recommendations to the Head of the Regulatory Governance Board as required
- 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
- Collaboration in designing the division/department strategy with the Head of the department/division as well as define strategic goals of partnerships with clients (e.g. contribution to RfP responses for large outsourcing projects)
- Support of marketing, business development and sales activities
- 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
- Several years of experience and broad knowledge in the field of Regulatory Operations and Regulatory information and system management. Strong knowledge and experience with Regulatory Affairs
- 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
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.