A Los Angeles, CA based bio tech company in business since 1997 is adding this role due to tremendous growth! We have 10+ drugs in various phases of development and partnerships with big pharma. We're a passionate, hands-on company that offers excellent compensation, benefits, bonus, cohesive culture and much room for growth and learning.
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.
Bachelor’s degree (or higher) in life sciences/scientific discipline
7-10 years of drug/biologic regulatory affairsexperience
Extensive knowledge of drug development process
Ability to operate independently
Excellent communication (verbal and written) skills
Knowledge of eCTD document structure