Regulatory Affairs Strategist

United States – RemoteRegulatoryRegular

Job Description

Kite is seeking a highly motivated individual to join us as a Regulatory Strategist, Global Regulatory Affairs, to work in the exciting area of cancer immunotherapy. This position will provide a combination of operational and strategic support within the Clinical Regulatory team of a dynamic and fast paced organization. The preferred candidate will possess strong interpersonal skills as this position interacts with all levels of employees in Clinical Operations, Clinical Development, Biostatistics, Patient Safety, Quality/Compliance, IT, and Regulatory Affairs.

Are you interested in helping ensure timely execution of clinical regulatory strategy in a cell therapy setting? Come join us in our mission to cure cancer!

RESPONSIBILITIES:

Supports Global and Regional Regulatory Leads in execution of clinical regulatory strategy
Completes or otherwise provides support in the preparation of routine regulatory submissions for commercial or investigational products in line with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) requirements, regional requirements, and scientific and company policies and procedures.
Works closely with cross-functional team and stakeholders to ensure timely execution of core regulatory deliverables
Performs document filing and retrieval functions in accordance with departmental standard operating procedures (SOPs).
Performs workflows and procedures regarding document tracking, indexing and retrieving, and disseminating information to others as needed.
With guidance, may participate in the development of routine labeling changes and drug listings.
Contributes to process improvements and/or other special projects within Regulatory Affairs.
Helps expedite and improve regulatory administrative activities by training and advising new or less experienced colleagues.
Seeks assistance from others as needed.
Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.

REQUIREMENTS:

PharmD/PhD with some relevant experience.
MA/MS/MBA with 2+ years’ relevant experience.
BA/BS with 4+ years’ relevant experience.
Extensive administrative experience in a corporate or related business work environment.
Some regulatory, quality, compliance or related work experience supporting medicinal products.
Experience writing or updating processes is preferred.

ADDITIONAL QULAIFICATIONS:

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.
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.
Demonstrates strong attention-to-detail and good organizational skills.
Demonstrates strong proficiencies in the Microsoft Office suite.
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.
Ability to support a team-oriented, highly-matrixed environment.
Ability to execute multiple tasks as assigned.
Knowledgeable with the drug development process, cell therapy industry, and Regulatory practices; eCTD submission experience strongly preferred
Ability to take initiative and think critically with demonstrated troubleshooting and problem solving skills
Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment
Comfortable negotiating and influencing in a fast-paced, dynamic, highly fluid, matrixed global organization and able to adjust workload based upon changing priorities
Proficient in MS Word, Excel, Power Point, SharePoint and Outlook; MS Project, Documentum, document formatting tools experience a plus