Sr. Manager, Regulatory Affairs CMC

Regulatory Affairs · San Diego, California
Department Regulatory Affairs
Employment Type Full Time
Minimum Experience Manager/Supervisor

Xencor is an innovative, clinical-stage biopharmaceutical company located in the Los Angeles area (near Pasadena) and in San Diego. We use our pioneering XmAb® technology to discover and develop better biotherapeutics – antibodies and other proteins with improved function – with the goal of improving patient outcomes and quality of life, and we have an excellent opportunity for a Manager or Sr. Manager, Regulatory Affairs CMC to join our team. 

 

The position will be Remote.

 

Our capabilities and the modular nature of XmAb technology allows us to quickly identify and create new platforms and drug candidates for potential development. We are developing a deep pipeline of novel drug candidates enabled by the rapid expansion of our bispecific antibody and cytokine technologies. Nine XmAb bispecific antibody programs are in clinical testing, and more are expected to start clinical testing in 2021. We also leverage our many XmAb technologies by engaging in multiple collaborations with leading global biopharmaceutical companies, including Novartis, Amgen and Genentech, among others. We and our partners are advancing 18 XmAb drug candidates through clinical development, and two medicines that incorporate XmAb technology are approved for commercial marketing.

 

Job Summary:

This position is responsible for assisting with establishing and managing regulatory systems and processes in accordance with worldwide, regional and local Regulations. This position is also responsible for oversight and execution of global Chemistry, Manufacturing and Controls (CMC) regulatory strategies and submissions, for product registrations (INDs, NDAs, IMPDs, CTAs, MAAs, DMFs, Amendments, Variations, etc.).

 

Job Duties Responsibilities:

  • Manage Regulatory submission process by collaborating and coordinating with relevant team members and participating in Core and Sub Team activities
  • Management of regulatory aspects of projects in collaboration with multidisciplinary teams according to project plans, timelines, and budgets
  • Contribute to quality related functions such as GMP requirements, draft and review SOP's, review quality and supplier agreements
  • Management of external regulatory and development of vendor resources.
  • Regulatory CMC lead for CMC regulatory strategies and plans to ensure alignment with the overall project plan and business strategy. Direct and lead regulatory execution of strategies and global regulatory submissions.
  • Develop and maintain product registrations
  • Lead, coordinate regulatory meeting packages and attend Regulatory Authority meetings
  • Assist in the management and oversight of regulatory activities relating to clinical trials globally on assigned projects
  • Assist with leadership of the regulatory team and provide guidance to the wider organization
  • Advise on labeling, promotional review and other post marketing/commercial regulatory activities
  • Represent the Company's interests with national government agencies, industry associations and/or other organizations with legislation, regulations and/or guidelines that impact the business in global markets
  • Perform other duties as required

 

Job Qualifications and Requirements: 

  • BS degree in a chemistry/engineering discipline or closely related field is required, advanced degree preferred
  • 4-6 years of relevant experience in the pharmaceutical/biotech industry
  • Knowledge of process development/manufacture and analytical methodology development/validation is desirable
  • Experience in formulation/process development is desirable

 

Required:

  • Authored CMC sections of regulatory filings for US, Europe, and Japan
  • Strong knowledge of current US and EU regulations and cGMPs
  • Strong experience with CTD format and content regulatory filings
  • Exceptional written and oral communication
  • Strong cross-functional team experience
  • Demonstrates strong problem solving and leadership skill sets

 

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. 

 

Physical Demands:

The physical demands described are representative of those that must be met by an employee to successfully perform the primary functions of this position.

 

The physical demands of the office are normally association with extended amounts of time sitting and using office equipment, including a computer, keyboard and mouse, which can cause muscle strain. While performing the duties of this job, the employee is frequently required to stand, walk and sit. Periodic light lifting of supplies and materials may apply. Work is performed in an office environment.

 

Americans with Disabilities Act (ADA) Statement

The Company will provide reasonable accommodations (such as a qualified sign language interpreter or other personal assistance) with the application process upon your request as required to comply with applicable laws. If you have a disability and require assistance in this application process, please contact HR@xencor.com.

 

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

 

Equal Employment Opportunity (EEO) Statement

The Company is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender or gender identity, national origin, disability status, protected veteran status or any other characteristic protected by state or federal law.

 

Xencor does not accept profiles or resumes from recruiting vendors without a binding written agreement. Any unsolicited submission of services and or resumes in no way creates an obligation or duty by Xencor, implied or otherwise.


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  • Location
    San Diego, California
  • Department
    Regulatory Affairs
  • Employment Type
    Full Time
  • Minimum Experience
    Manager/Supervisor