Director, Regulatory Affairs - San Diego, CA | Biospace
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Director, Regulatory Affairs

Xencor

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Location:
San Diego, CA
Posted Date:
9/5/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Director, Regulatory Affairs,

Job Description


We seek a Director, Regulatory affairs to work directly with department representatives on the Project Team to assure integration of Regulatory Affairs across all the operative functions, including clinical development, CMC, QA, and preclinical development.

Job Duties include:

•   Providing management and leadership in the RA organization in the development and implementation of regulatory strategies and processes.
•   Responsible for leading Project Teams on steps necessary to comply with regulations and guidances.
•   Determining regulatory requirements for clinical and pre-clinical submissions to FDA for Xencor investigational products.
•   Maintaining timelines and developing and coordinating content for submission to FDA and other regulatory agencies
•   Coordinating and preparing responses in response to Regulatory Agency requests. Ensuring regulatory commitments are met for assigned projects.
•   Acting as liaison with the FDA for assigned products and representing Xencor before regulatory authorities, including preparation of meeting agendas, materials, and minutes.
•   Maintaining active INDs as necessary.
•   Assisting in the development and maintenance of departmental processes, policies, SOPs and associated documents.
•   Maintaining awareness of existing and new regulations and guidances affecting Xencor products.

Requirements


Qualifications/Requirements:

•   Bachelor’s degree (or higher) in life sciences/scientific discipline
•   7-10 years of drug/biologic regulatory affairs experience
•   Extensive knowledge of drug development process
•   Ability to operate independently
•   Excellent communication (verbal and written) skills
•   Knowledge of eCTD document structure