- Global Regulatory Affairs Project Leader -
International Pharmaceutical Company (Noord Brabant)
We have an exciting opportunity for a two-year contract for a Project Leader (Senior Specialist) to lead the cross-functional EU Telematics project team.
- Lead a multidisciplinary project team in charge of the implementation of the New Veterinary Regulations
- Develop and execute project plans to ensure that business processes as well as regulatory information systems and platforms are brought in line with the new EU Telematics landscape as defined by the EMA
- Maintaining close contact with internal stakeholder groups
- Assess regulatory impact for approved products
- Provide clear communication towards project team members and globally impacted colleagues and necessary training
- experience in Life Sciences with focus on regulatory data management, quality management, manufacturing, supply chain or compliance
- experience with EU authorities / registration process and experience with project management
- knowledge of EU Telematics (IDMP, UPD, SPOR, CESSP)
- fluency in English
- experience with regulatory information systems and platforms (CESSP, Veeva) and EU registration processes is an advantage
Are you ready to take a new step in your career? If you are interested or know someone who is, contact me and upload your CV via the apply button.