Peersight
Employers
Jobs
Companies
Top Cities
Log In
Jobs
Truck Driver Position Occupational Therapist 0 0 PR Digital Marketing Intern Delivery Driver Paid Healthy Trial Participant Paid Clinical Trial Participant Paid Research Participant BairesWash Incorpora Personal Para Software Developer Bread Baker Dental Receptionist-Full Time Driller Delivery Driver Carpenter Bud Tender Hiring Mortgage Agents and Brokers Marketing Assistant Amazon Picker Amazon Warehouse Associate - Immediate Amazon Warehouse Associate - Immediate Amazon Order Packer Seasonal Full-Time Warehouse Team Member Amazon Picker Amazon Warehouse Associate Full-Time Warehouse Team Member Amazon Warehouse Worker Amazon Picker Amazon Picker Amazon Warehouse Associate - Immediate Amazon Picker Full-Time Warehouse Team Member Amazon Picker Amazon Picker Amazon Warehouse Worker Amazon Warehouse Associate - Immediate Amazon Warehouse Associate - Free Amazon Warehouse Worker Amazon Warehouse Worker Amazon Warehouse Associate Amazon Order Packer Amazon Warehouse Associate - Free Seasonal Full-Time Warehouse Team Member Amazon Warehouse Worker Amazon Picker Amazon Warehouse Worker Full-Time Warehouse Team Member Amazon Warehouse Worker Newest Jobs
Companies
Yelp ContactMonkey CareGuide Clearbanc Sterling-Turner Exact Media Aerotek Two Sigma Aecom Peel Regional Police AsteroidX Akira Jane Street Borrowell Insight Global WeWork Shopify First Convenience Bank American Income Life Doordash Amazon Flex Square Microsoft AT&T Instacart Clickworker Vector Marketing Scotiabank Creative Circle Hatchways Walgreens UnitedHealth Group Recovhub LowCostWebDesignFirm.com Desjardins CI&T mappedin 51talk Top Hat Checkout 51 Paylocity Mobeewave TD Bank The Youth Connection Hootsuite SnapTravel ScribbleLive autoTRADER.ca GoParkr Xiaomi All Companies
Top Cities
Chicago, Illinois Sales Jobs Engineering Jobs Marketing Jobs Product Jobs Design Jobs Customer Support Jobs New York, New York Sales Jobs Engineering Jobs Marketing Jobs Product Jobs Design Jobs Customer Support Jobs Toronto, Ontario Sales Jobs Engineering Jobs Marketing Jobs Product Jobs Design Jobs Customer Support Jobs Vancouver, British Columbia Sales Jobs Engineering Jobs Marketing Jobs Product Jobs Design Jobs Customer Support Jobs Calgary, Alberta Sales Jobs Engineering Jobs Marketing Jobs Product Jobs Design Jobs Customer Support Jobs San Francisco, California Sales Jobs Engineering Jobs Marketing Jobs Product Jobs Design Jobs Customer Support Jobs Montréal, Quebec Sales Jobs Engineering Jobs Marketing Jobs Product Jobs Design Jobs Customer Support Jobs Los Angeles, California Sales Jobs Engineering Jobs Marketing Jobs Product Jobs Design Jobs Customer Support Jobs
Navigation
My Profile Log Out

Senior Manager, Regulatory Affairs At Kite Pharma

Location: Santa Monica, California

Job Description

For Current Kite Pharma Employees and Contractors:

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


Job Description


The Senior Manager, Regulatory Affairs will be able to work in a matrix environment and possess the credentials to be the US lead in providing both strategic input and day to day guidance for the projects assigned.

Responsibilities (include but are not limited to):

  • Provide regulatory guidance to cross-functional teams ensuring the project assigned progresses from IND stage to launch within company agreed timelines.
  • Ensure regulatory compliance with relevant regulations and effectively managing timely submissions to the appropriate regulatory authorities
  • Manage the preparation of applications and subsequent regulatory documents, pre and post approval in accordance with agreed timeframes
  • Ensure submission-readiness of all regulatory documents related to the project
  • Ensure that documents to be submitted to the health authorities are compliant with eCTD submission requirements.
  • Format documents per Kite Style
  • Assist in developing junior regulatory affairs staff.
  • Determine risk assessment and implement regulatory strategies for products in pre and post-approval stages.
  • Build long term effective relationships and open communication with cross functional teams in order to provide accurate information and timeframes.
  • Participate in R&D meetings to discuss project issues and develop priorities to produce clear project plans.
  • Participate in inter-departmental meetings to discuss project issues and priorities and develop clear plans to achieve the required goals.
  • Develop and maintain a positive working rapport with the regulatory agencies
  • Develop and maintain standard operating procedures or local working practices
  • Maintain current knowledge of relevant regulations, including proposed and final rules


Requirements:

  • BA/BS and 8 years, MA/MS and 6 years, or PhD/PharmD and 3 years of relevant US regulatory (FDA) / drug development experience
  • Good communication skills – both oral and written
  • Organizational skills – detail oriented and can deal with frequent changes in product activity
  • Strong knowledge of eCTD elements and structure
  • Strong team player that has a customer service approach and is solution oriented
  • Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies
  • 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)
  • Expertise with templates and formatting tools
  • 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


#LI-TM1