Associate, Regulatory Affairs, Advertising and Promotion

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Oct 18, 2019
Ref
R0010289
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 an Associate, Regulatory Affairs, Advertising and Promotion to support Regulatory Promotion filings and activities with regard to marketed and clinical products.

Responsibilities
  • Providing operational support in the area of Promotional Review Committee (PRC) process at Kite Pharma in Santa Monica.
  • Support the cell therapy therapeutic area based on the individual candidate experience and related business priorities. Under the supervision of the Manager in RA Ad/Promo, will lead the submission of promotional materials for marketed prescription drug or biologic products to Advertising and Promotional Labeling Branch (APLB) at the time of first use (2253 submissions), as well as other PRC and Regulatory-related functions.
  • Manage the submission of promotional materials for advisory comments, represent the RA Ad/Promo group on working groups related to submission processes, collaborate with the PRC teams, etc.
  • Support members of the RA Ad/Promo group by conducting regulatory specific research and providing updates to the group on OPDP enforcement letters.

Minimum Qualifications
  • BA/BS degree and one year of Regulatory Affairs related experience.
  • Strong understanding of the role of Ad Promo within Regulatory Affairs
  • Excellent interpersonal, verbal and written communication skills, attention to detail, and ability to facilitate multiple projects/priorities at any given time, are required.


Preferred Qualifications
  • Knowledge of Regulatory submission requirements (ie 2253), Veeva Vault, and PRC/MLR experienced is desired.


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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