Head of Regulatory Affairs
Our client is dedicated to advancing aesthetic medicine, driven by scientific innovation and a commitment to premium skin treatments.
We’re seeking a skilled Head of Regulatory Affairs to ensure compliance with global regulations and uphold top-notch quality standards.
This pivotal role involves crafting regulatory strategies as well as hands-on driving and overseeing submissions.
We’re in search of an experienced leader to manage a dedicated team of Regulatory Affairs professionals. This role entails a focus on the aesthetic portfolio and cross-functional responsibilities. Reporting to senior management, the position requires strong leadership, regulatory expertise, and the ability to collaborate across functions throughout the product lifecycle.
- Define and lead the work for the company’s regulatory strategy and coordinate regulatory teams around the world (EMEA, CENAM, APAC)
- Act as the main point of contact with competent regulatory authorities and Regional/Country regulatory leaders.
- Provide RA support for the activities associated with new potential partnering, and due diligence for in- and out-licensing activities.
- Representation of the Regulatory department during official regulatory audits and inspections
- Lead cross-functional and cross-organizational topics and teams to build and maintain global processes and relationships.
- Experience with Biological Product registration and specifically Botulinum Toxin is a must
- Advanced university degree in life sciences. PhD or Master’s Degree in the biotech/Pharma or diagnostic industry would be preferential
- Significant experience in pharmaceutical and medical devices Regulatory Affairs and Pharmacovigilance on a global/international level
- Minimum of 10 years experience in Regulatory Affairs and Medical Devices
***Please forward your application should you meet the requirements above – applications which do not meet these requirements will not be considered***