Senior Manager Regulatory Affairs
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 seeking a highly motivated Senior Manager to join our Regulatory Affairs team. In this exciting role, you will support cross-functional teams in innovative approaches to medicinal products development of any stage – from research, throughout clinical development until MAA.
Location: Switzerland, Austria, Germany, hybrid, remote
Required competencies
Defining regulatory strategy and project plans for assigned project
Preparation, review and compilation of documents within the framework of regulatory affairs projects
Participation in regulatory processes to gain and maintain marketing authorizations for medicinal products
Communication with clients and Health Authorities
Advanced degree in pharmaceutical sciences, medicine, or life sciences
Proven experience with Swiss or EU regulatory procedures for medicinal products
Ability to understand and to communicate complex development scenarios
Strategic thinker, solution oriented, excellent prioritization skills
English business fluent, German knowledge is a plus
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.