Manager, Regulatory Affairs CMC

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Nov 18, 2020
Ref
R0016145
Required Education
Doctorate/PHD/MD
Position Type
Full time
Kite is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job

Job Description

Everyone at Kite is grounded by one common goal - curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!

We are seeking a Manager, Regulatory Affairs CMC to join our rapidly expanding team in Santa Monica, California. This incumbent will demonstrate technical command of Module 3 Regulatory governance including harmonization across cell therapy programs globally.

Responsibilities (include but are not limited to):
  • All operational and life cycle management aspects of regulatory CMC submissions (e.g. IND, IMPD, BLAA, and MAA) in support of commercial and developmental programs.
  • Function as the Regulatory CMC lead on program teams by applying advanced knowledge of regulations and interprets technical regulatory guidelines to ensure that regulatory submissions are in compliance with applicable regulations
  • Strategize on deliverables to ensure M3 content meets regulatory requirements and projected business timelines
  • Identify CMC risk areas and develop alternative courses of actions including anticipation of regulators responses through scenario planning and development of contingency plans
  • Align CMC regulatory strategy to overall regulatory business strategy (e.g. upcoming process, raw material, shelf-life and analytical changes)
  • Responsible for assessment of all CMC related changes
  • Provide regulatory CMC expertise during due diligence and in support of new projects
  • Provide leadership to rapidly adapt strategy to unanticipated changes
  • Lead and coordinate the timely compilation and critical review of the CMC data package from other functional team representatives to provide complete and appropriate documentation necessary for timely world-wide registration.
  • Participate in Project team and lead technical task force meetings leading on RA/CMC related activities.


Basic Qualifications:
  • PhD with 3+ years of Regulatory Affairs experience OR
  • MS with 5+ years Regulatory Affairs experience OR
  • BS with 7+ years of Regulatory Affairs experience OR
  • Associate's Degree with 9+ years of Regulatory Affairs experience OR
  • High School Diploma with 11+ years of Regulatory Affairs experience


Preferred Qualifications:
  • Good communication skills - both oral and written
  • Organizational skills - detail oriented and can deal with frequent changes in product activity
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • High level of proficiency in relevant software (i.e., MS Word, MS Office or similar systems, Adobe)
  • High energy level and a positive outlook coupled with the requisite "can do" attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles
  • Willingness to think outside of the box and adapt best practices to our small, but growing environment
  • Ability to adapt in a constantly evolving environment
  • Self-motivated with a strong sense of ownership in areas of responsibility
  • High degree of professionalism, ethics and integrity
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities


Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

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For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.