Sr. Manager, Regulatory Affairs
Xencor Inc. is an innovative biotechnology company located in the Los Angeles area (near Pasadena) and in San Diego. We have a very deep drug development pipeline including three programs currently in clinical testing with one more expected to start clinical testing in 2017 and have an excellent opportunity for a Sr. Manager, Regulatory Affairs to join our team. We use our pioneering XmAb® technology to develop better biotherapeutics – antibodies that target new biological mechanisms and have the potential to be more potent, safer and longer lasting – with the goal of improving patient outcomes and quality of life. In addition to generating a pipeline of novel drug candidates, with ten in clinical testing by Xencor or our partners, our XmAb® technology has enabled multiple collaborations with leading biopharmaceutical companies including Novartis, Amgen, Morphosys, Merck, CSL, Janssen(J&J), Alexion and Boehringer Ingelheim.
Our employees are the most important factor in our success and we have assembled a highly talented group from diverse backgrounds and disciplines to execute our business plan and shape our future. Xencor employees value new ideas and flexibility and demand from each other scientific rigor, a passion for innovation, and a willingness to take risks.
We seek a Sr. Manager, 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.
- 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.
- 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 guidance’s affecting Xencor products.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
- Bachelor’s degree (or higher) in life sciences/scientific discipline
- 3-6 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
We strive to create an environment that will challenge, motivate, and reward our employees for meeting the changing demands of creating breakthrough therapeutics. Xencor has a highly collaborative structure that integrates co-workers with different skill sets into teams for product and technology development. With an emphasis on attaining the best and most highly qualified candidates in their respective fields, we offer a competitive salary & benefits package. Please submit a cover letter & resume. For further information about Xencor, please visit our website at www.xencor.com EOE