Experienced Regulatory Affairs Professionals
At Luminance Health we foster meaningful growth in Life Science.
With our cross-functional consulting services, we support pharma, biotech and medtech organizations to achieve sustainable success and continuously uphold industry standards while navigating dynamic and international regulatory landscapes across the lifecycle of medicinal products, devices, IVDs and combination products.
We provide personalized, expert-led, cross-functional support in development, regulatory affairs, quality assurance, pharmacovigilance, medical and regulatory communications, market access, public affairs, healthcare compliance, project management, establishing and scaling-up companies.
With our offices in Switzerland and Austria as well as our strategic partners across the globe we support access to markets for our clients globally.
We are expanding our team with experienced European and Swiss Regulatory Affairs professionals.
Location: Switzerland, Austria, hybrid, remote
Required competencies
Define regulatory strategy and project plans for assigned project
Oversee and lead preparation of CTA & MAA dossier
Deliver high quality and efficient regulatory submissions
Lead cross-functional meetings with regulatory agencies
5 years+ working experience in regulatory affairs
Solution-oriented mindset
Analytical and strategic thinking
Excellent negotiation skills
Attention to detail
Excellent verbal and written English communication skills
We are a people-centric company with a purposeful mission putting the team and a positive company culture at first place. Integrity, ethical mindset and long-term sustainable relationship with our team, business partners and stakeholders build the fundament of our culture, and we offer continuous development and growth opportunities.