The main purpose of this position is to provide global leadership and supervision of relevant regulatory matters, as well as drive and implement a consistent overall regulatory strategy.
- Act as primary representative for the regulatory affairs function
- Be the intermediary to relevant technical units
- Provide advice on a global level, as well as design and implement the overall regulatory strategy for products at various stages (development, change, clinical trials etc.)
- Evaluate current guidelines and make improvements, carry out risk analyses, and suggest mitigations
- Support training initiatives and meet with relevant stakeholders to disperse information
- Be responsible for all relevant regulatory affairs administration
- University level degree in a scientific field – further studies in Regulatory Affairs is a plus
- At least 8 years of experience in the pharmaceutical industry, and at least 4 in regulatory affairs
- CMC Regulatory Affairs experience
- Strong regulatory knowledge, on a global / international level
- Fluent in English, other languages a plus
Our client offers the chance to work for a reputable and international company, with excellent benefits and work-life balance. If you think you profile is a good fit and would like to learn more, please share with me your CV at email@example.com
Look forward to hear from you!