At Kite, we are at the forefront of immunotherapy and engineered T cell therapy. We are helping change the paradigm of cancer treatment and we are revolutionizing individually tailored treatments. That means a fast moving and constantly changing environment, where we make discoveries every day – discoveries that include our own capabilities and our individual potential.
LOCATION: Can be located in Amsterdam, London, Cambridge or Zug – we are open to applications for these locations.
FUNCTION: Regulatory CMC Europe
Lead moderately complex regulatory submissions for the assigned product or project; seeking guidance from other colleagues as needed. Prepare CMC regulatory submissions for commercial or investigational products with minimal guidance. Work cross-functionally with sub-teams, such as CMC submission teams. Liaise with head quarters colleagues to provide feedback to the European and intercontinental team on submission content for first market submissions. Works with the team on regulatory projects that require updates to processes due to changes in regulations such as the implementation of the 2014 clinical trial regulation in the EU.
Supports, prepares, and completes moderately complex regulatory submissions, which require interactions with cross-functional groups, for commercial and investigational products in line with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) requirements, regional requirements, and scientific and company policies and procedures.
Helps review regulatory content and packages for completeness and accuracy
Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.
Performs document filing and retrieval functions in accordance with departmental standard operating procedures (SOPs).
Performs workflows and procedures for EU variations, makes necessary updates to the document inventory , and disseminates information to others as needed.
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
Education & Experience
Advanced degree in life sciences and 2+ years’ relevant experience in CMC related regulatory affairs.
BA/BS or equivalent with 4+ years’ relevant experience in CMC related regulatory affairs.
Strong life sciences background, ideally in cell & gene therapy
Knowledge & Other Requirements
Demonstrated ability to be a fast learner.
Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
Demonstrates sound knowledge of regulatory requirements and the role of regulatory affairs as these pertain to medicinal products, including knowledge and understanding of ICH standards and varying regional requirements in the assigned markets.
Demonstrates strong attention-to-detail and good organizational skills.
Demonstrates strong proficiencies in the Microsoft Office suite.
Ability to communicate in a clear and concise manner.
Ability to support a team-oriented, highly matrixed environment.