My client is a privately held Belgium-based respiratory company focused on the development of pharmaceutical products with superior clinical performance based upon differentiated technology delivered by their next generation Soft Mist Inhalation device to the lungs.
As a Regulatory Senior Manager you will have the following responsibilities:
- Reporting to the Head of Regulatory, you’re responsible for developing and implementing global strategies for obtaining and maintaining Marketing Authorisations for the portfolio of Soft Mist Inhalation products.
- As member of the development team you’ll work within a complex matrix environment with multiple stakeholders and on cross-functional teams to advise on drug development process, dossier requirements and global regulatory procedures.
- You’ll lead engagement with Regulatory Agencies to agree supporting data packages.
Interested? For this position you’ll need the following education, experience and skills:
- You have a bachelor or higher degree in pharmaceutical, biomedical or chemical science or related.
- You have at least 6 years’ experience, ideally in pharmaceutical regulatory affairs.
- You have a good understanding of the drug development process, dossier requirements and global regulatory procedures for gaining approval and maintaining Marketing Authorisations (US, EU, MENA, UK, LATAM)
- Experience of inhaled drug device combination products or medical devices would be advantageous.
- You have experience or a great interest in respiratory diseases.
- You have strong project and people management skills
Why you should apply
This is a fantastic opportunity to work for a leading innovative company developing respiratory products for the treatment of indications such as asthma and COPD. The role will provide a dynamic and stimulating working environment as well as flexible hybrid working.