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Regulatory Strategist, Global Regulatory Affairs
Company | Kite Pharma |
Address | Santa Monica, CA, United States |
Employment type | FULL_TIME |
Salary | |
Category | Biotechnology Research |
Expires | 2023-05-25 |
Posted at | 1 year ago |
For Current Kite Pharma Employees and Contractors:
- Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.
- Contributes to process improvements and/or other special projects within Regulatory Affairs.
- With guidance, may participate in the development of routine labeling changes and drug listings.
- Helps expedite and improve regulatory administrative activities by training and advising new or less experienced colleagues.
- Performs document filing and retrieval functions in accordance with departmental standard operating procedures (SOPs).
- Seeks assistance from others as needed.
- Completes or otherwise provides support in the preparation of routine regulatory submissions for commercial or investigational products in line with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) requirements, regional requirements, and scientific and company policies and procedures.
- Performs workflows and procedures regarding document tracking, indexing and retrieving, and disseminating information to others as needed.
- High School Diploma/GED and 6+ years of relevant experience
- Associate and 5+ years of relevant experience OR
- Bachelor’s and 4+ years of relevant experience OR
- Master’s and 2+ years of relevant experience OR
- Knowledgeable with the drug development process, cell therapy industry, and Regulatory practices; eCTD submission experience highly preferred
- Ability to take initiative and think critically with demonstrated troubleshooting and problem solving skills
- Comfortable negotiating and influencing in a exciting, adaptable, highly fluid, matrixed global organization and able to adjust workload based upon changing priorities
- Good project management skills, as evidenced by ability to manage multiple assignments simultaneously without compromise to timelines or quality.
- Ability to communicate in a clear and concise manner.
- Extensive administrative experience in a corporate or related business work environment.
- 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.
- Ability to support a team-oriented, highly-matrixed environment.
- Some regulatory, quality, compliance or related work experience supporting medicinal products.
- Demonstrates meaningful proficiencies in the Microsoft Office suite.
- Demonstrates meaningful attention-to-detail and good organizational skills.
- Ability to implement multiple tasks as assigned.
- Experience writing or updating processes is preferred.
- Proficient in MS Word, Excel, Power Point, SharePoint and Outlook; MS Project, Documentum, document formatting tools experience a plus
- Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment
- 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.
- Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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