Regulatory Affairs

Regulatory Affairs

USA / Switzerland

Description

Kodiak Sciences aspires to global leadership in ophthalmology by aggregating top talent, technologies, discoveries, and ideas. We are working to develop disruptive products and platforms to prevent and treat the leading causes of blindness.

Kodiak Sciences is expanding its Regulatory Affairs team and is seeking highly motivated and talented experts in medicines development, technical / CMC, and devices to join our Regulatory Affairs team. The group is leading the preparation of complex global regulatory strategies and is responsible for the compilation of all necessary documentation for regulatory submissions. Individuals in these roles play a crucial role in ensuring the timing, high-quality, and content of our submissions. The team drives the overall operational process of cross-functional teams, including the implementation of innovative tools and methods. Team members will have the opportunity to drive strategy and communications with key global regulators, including FDA and EMA. We are looking for candidates who will help with the long-term team vision and execute on the strategy with an expectation to scale-up efficiently and rapidly.

We have various opportunities in Palo Alto and Switzerland.