Team Leader Regulatory Affairs
Providing Flexible Resourcing Solutions
CTC Clinical Trial Consulting, founded in Basel, Switzerland in 1997, is a specialist staffing organisation, providing flexible resourcing
solutions to the pharmaceutical industry in Switzerland, with contract and permanent placements in clinical development, data management,
statistics, regulatory affairs and medical marketing.
For one of our clients, we are currently looking for a
Purpose:
To lead the Regulatory Affairs Team and to monitor and plan Regulatory Affairs projects in order to maintain existing registrations, as well as obtaining new registrations according to the company strategy.
Main Responsibilities:
- To manage a Regulatory Affairs Team: Provide organisational,
technical and disciplinary leadership - Responsibility for the target-oriented implementation of tasks within the Regulatory Affairs team with optimal application of the available resources
- Guidance and supervision of Global Regulatory Affairs Projects on Global Brand Team level: Responsibility for planning, organisation and processing of the designated Regulatory Affairs projects and adherence to the respective time limits and budget
- Supervision of the group-specific tasks within the framework of assuring regulatory compliance, administration of regulatory dossiers and guaranteeing the tracking of regulatory history
- Obligation to keep up to date on the latest regulatory requirements
- Cooperation with authorities, and with internal and external partners
- Interface with other departments and offices at a national and international level
- Development and empowerment of team members. Carrying out individual performance and development reviews. Definition of objectives and training measures. Carrying out of training measures with adherence to internal procedures, guidelines and SOPs
- Monitoring of development projects, under realisation of regulatory requirements
Qualifications and Experience:
- Academic degree in the fields of natural sciences
or medicine or equivalent professional experience - At least 5 years experience in Regulatory Affairs or in the pharmaceutical industry
- Experience in managing people (disciplinary and functional)
- Leadership qualities, diplomacy and respectful behaviour
- Good communication and negotiation skills at all levels and absolute discretion in the handling of confidential documentation and information
- Creative, solution-oriented work approach
- Accuracy, flexibility and the ability to work under pressure
- Ability to work in interdisciplinary teams
- Strategic thinking and acting, strong analytical qualities
- High level of computer proficiency in Microsoft Office, Internet, databases
- Fluent in both written and spoken German and English
- Relevant working/residency permit or Swiss/EU-Citizenship required
Our offer:
- Competitive salary and package
- Interesting and challenging opportunities
- The possibility for development and advancement within a growing and dynamic company
July 5, 2010
• Tags: Switzerland Job in Eastern Switzerland, Team Leader Regulatory Affairs • Posted in: General