Senior Associate, Regulatory Affairs CMC

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Sep 29, 2019
Ref
R0010087
Hotbed
Biotech Beach
Required Education
Associate Degree
Position Type
Full time
Do you want to make a real difference in the world? Come help us in our quest to cure cancer! Everyone at Kite is grounded by this common goal. 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 capable Regulatory CMC professional to join us at the Senior Associate level and support current and upcoming cell therapy Investigational New Drug (IND) submissions.

Responsibilities
  • Responsible for preparing the CMC sections of regulatory submissions which require some interactions with others in the Regulatory department for investigational and commercial products in line with ICH requirements, regional requirements and scientific and company policies and procedures.
  • Will have increasing responsibility for preparing submissions, which may include, but is not limited to: reports, amendments, supplements and license renewals to clinical trial applications and marketing authorizations.
  • Provides input to the development of labeling and submit labeling changes, and drug listing. Participate in group meetings and provide tactical approaches to addressing problems of moderate complexity.
  • Responsible with manager for development and acquisition of required regulatory skills and knowledge.
  • Contributes to local process improvements, which have an impact on the working of the Regulatory Affairs function or other departments.
  • Act as a resource on limited topics within the department.
  • Work is performed under the general supervision of more senior Regulatory Affairs professionals.
  • Work is reviewed for soundness of judgment and overall adequacy.


Requirements
  • 6+ years of Regulatory Affairs and/or related experience (preferably in GMP environment) with Bachelor's degree, 4+ years with Master's degree, or 2+ years with PhD
  • Minimum BS Degree in a scientific discipline, advanced degree preferred


Additional Qualifications:
  • Excellent organization skills and ability to work on a number of projects with tight timelines.
  • Excellent verbal and written communication skills and interpersonal skills are required.
  • Reasonable understanding of regulatory requirements, including ICH requirements and regional requirements for assigned territories.


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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