Senior Specialist Project Leader
This (bio-)pharmaceutical company is located in Boxmeer. They develop and produce veterinary vaccines and medication.
A big number of important vaccine development functions all under one roof. Research, Development, Production, Quality Control, Logistics, Marketing and Sales are all located in Boxmeer. With a big team this company often shows how innovative they are, collaborating with different teams and locations all over the world.
Within the Global Regulatory Affairs department they are looking for a Senior Specialist Project Leader. This department is responsible for the regulatory data and document infrastructure, electronic publishing of registration files and the global management of labelling documents for Biologicals and Pharmaceutical products.
As a Senior Specialist Project Leader you will lead a multidisciplinary project team in charge of the implementation of new regulations. Develop and execute project plans, ensuring that all company business processes as well as regulatory information systems and platforms are in line with the new landscape.
Maintaining close contact with internal stakeholder teams, such as Global Regulatory Affairs, EU Country Regulatory Affairs (CORAs), Pharmacovigilance, IT, Sales
- Assess regulatory impact for approved products and work closely with other Global Regulatory Affairs departments ensuring preparation and execution of product variations if required
- Closely follow discussion at EMA and Industry Association and participate to external meetings as needed
- Providing a clear and structured overview of all planned activities and required resources to ensure adherence to project timeline
- Master or PhD in Life Sciences
- Background in the (bio-)pharmaceutical industry with a focus on Regulatory Data Management, Compliance or Quality Management
- Experience in Project Management and multi-disciplinary Project teams
- Knowledge of regulatory information systems and platforms
- EU Registration processes is advantageous
If you want to apply please submit your CV via the button below.