The role involves developing regulatory strategy for novel advanced therapy medicinal products treating cancer and autoimmune diseases in the EU and international markets
Job Summary
The role involves developing regulatory strategy for novel advanced therapy medicinal products treating cancer and autoimmune diseases in the EU and international markets.
Candidates must prepare moderately complex regulatory submissions and interact with global leads to align on delivery strategies for ACE regions.
Kite Pharma offers a flexible working policy with two days of remote work and three days onsite at their Cambridge or Stockley Park offices.
Matching Summary
The role involves developing regulatory strategy for novel advanced therapy medicinal products treating cancer and autoimmune diseases in the EU and international markets.
Skills & Requirements
Must-have
Regulatory strategy for ATMP products
Clinical Trial Application preparation
EU regulatory requirements knowledge
Cross-functional team collaboration
ICH and regional compliance expertise
Nice-to-have
Strong presentation and communication skills
Ability to work under pressure
Strategic thinking and problem solving
Experience with document management systems
Influence on cross-functional planning
Key Requirements
Life Science degree required
Experience with centrally approved product submissions
Proven experience leading clinical trials applications in the European Union