Be a part of our growing company!
Are you eager to work in a dynamic company where new challenges and opportunities are part of your everyday life? Then make PharmaLex your career choice! PharmaLex is the leading service provider for the worldwide pharmaceutical industry in regulatory affairs, pharmacovigilance and development consulting. We specialize in effectively designing all aspects of drug and medicinal product registrations – ranging from early development and market entry to product maintenance activities. The success of our company resides in the expert knowledge and high motivation of our employees.
We are looking for motivated, committed candidates who will enjoy working independently within our successful team in a challenging environment. So, if your career is much more than just a job for you but rather your passion, then come and join our successful team. In Sofia, we are looking for a Regulatory Data Management Team Coordinator.
Regulatory Data Management Team Coordinator
- Leading and coordinating a team of Regulatory data management and regulatory document support specialists;
- Managing client’s and project lead’s expectations and taking overall responsibility for team’s results;
- Developing appropriate data management and pre-publishing procedures and manuals/guides;
- Build up and manage a shift-based Regulatory data management service model, covering 24/7 support;
- Ensure operational expertise for regulatory document support & pre-publishing team, including Word and PDF formatting/pre-publishing activities for EU, US and global submissions;
- Supporting client system audit or GxP inspections in close collaboration with the Regulatory Information Management Lead and Quality Management
- Providing training for various groups of Regulatory system users (incl. preparation and maintenance of training material);
- Mentoring of junior employees within the department/the division/the company in the area of Regulatory data management;
- Manage Administrative tasks related to Efficiency reporting and Project staffing as well as Resource management and regulation and steerage of vacation periods, working hours (e.g. overtime)
- Play active role in Employee retention and development with focus on regular employee communication and annual performance review. Provide active employee feedback/performance assessment.
- Degree in Business, Economics, Pharma/Life science or another administrative field;
- >5 years of experience and broad knowledge in the field of Regulatory Operations and Regulatory information and system management as well as Regulatory document support and pre-publishing activities (preferably for EU, US and world-wide submissions)
- Practical experiences with validated (acc. to 21 CFR Part 11) resp. GxP-relevant systems;
- 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;
- Ability to anticipate potential risks and opportunities within the scope of the team coordinator’s role;
- Good ability for self-reflection and provides the required professional attitude
- Fluent in business English.
- Opportunity to conquer exciting and varied challenges alongside a talented team;
- Option for flexible working hours;
- Open and collaborative organizational culture with an emphasis on knowledge-sharing;
- Business interaction with nearly all branches of the company across 5 continents;
- A broad range of initiatives for personal development and professional training.
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.
For further information please don’t hesitate to contact us:
Manager Human Resources
Agencies only by prior agreement for the specific job opportunity.