Atara Biotherapeutics, Inc.

  • Senior Manager/Associate Director, Regulatory Affairs

    Job Locations US-CA-Thousand Oaks
    ID
    2019-1109
    Category
    Regulatory Affairs
    Type
    Regular Full-Time
  • Job Description

    Position Summary

    This position supports all regulatory affairs activities for the company’s products, including but not limited to collecting and summarizing regulatory intelligence, performing regulatory assessments, participation in project teams, providing input for regulatory submissions, and managing the compilation and review of all submissions for completeness and quality.

     

    Primary Responsibilities

    • Manage regulatory projects and closely collaborate with Clinical, Regulatory Operations, other scientific and technical departments and external vendors to coordinate and implement submission strategy and content in a global clinical bio-pharmaceutical development environment.
    • Provide updates on strategic regulatory intelligence, such as new regulations, guidance, ODACs, competitive product applications and approvals, etc.
    • Provide regulatory intelligence to inform regulatory strategies, including scenarios for the earliest regulatory approvals possible as well as an assessment of risk for each of the various scenarios.
    • Provide tactical support for the timely preparation, editing and review of submissions, including regulatory agency Meeting Requests and Briefing Documents, IND/CTA amendments, original BLAs and international Marketing Authorization Applications and their respective amendments/supplements.
    • Coordinate and manage regulatory submission documents (e.g., cover letters, Meeting Requests, Meeting Briefing Packages, etc.) to produce submission ready content. Coordinate interdepartmental team review and approval of submission document deliverables including: distribute drafts, attend/steer review meetings, and incorporate revisions.
    • Manage the quality, accuracy, compliance with internal and external standards, and the timely production of submission documents using manual and electronic document management systems such as Veeva, as appropriate.
    • Work with Regulatory Operations or publishing vendors to compile and review regulatory submissions for completeness and quality, ensuring that Atara’s practices are in conformance with the latest health authority and industry submission standards.
    • Assist with logging, tracking and filing of correspondence with regulatory authorities and ensuring that no commitment remains unduly outstanding.
    • CMC regulatory expertise is a plus

    Skills and Abilities

    • Takes ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary.
    • Understands and interprets data/information and its practical application 
    • Strong communication skills (e.g., clear and concise), team player, and proven negotiation skills.
    • Strong understanding of pharmaceutical biologics drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, project management, and medical terminology.
    • Working knowledge of manufacturing research and development. CMC regulatory experience, and/or knowledge of cellular therapies manufacturing, and quality development would be an advantage.
    • Strong time and project management skills.
    • Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution.
    • Self-motivated, flexible and creative leader, able to prioritize, multi-task, and work in a fast-paced & demanding environment.

    Reports to:                      Senior Director in Regulatory Affairs

     

    Location:                         Thousand Oaks, CA

    Qualifications

    Education and Professional Experience

    • Bachelor’s degree (MS preferred), in Life Sciences/Health Related field, from an accredited college or university with 10 or more years drug development or related experience with 5+ years in Regulatory Affairs.
    • Extensive knowledge of regulatory requirements.
    • Proficient in pertinent software & tools.
    • Must be knowledgeable in industry trends for study reports and dossier preparation (e.g., IND/CTA/NDA/NDS), including electronic document submissions (i.e., eCTD).

    Physical Requirements:

    Subject to extended periods of sitting and standing, vision to monitor and moderate noise levels. Work is performed in an office environment. 

     

    Travel:                                 Travel may be required (up to 10%).

    More about Atara Bio

    We launched Atara Biotherapeutics in August 2012 to help patients with serious diseases and few therapeutic options. We’re named after Atara Ciechanover who suffered from cancer before passing away. We are considered a leading off-the-shelf T-cell immunotherapy company (Nasdaq ATRA) developing novel treatments for patients with cancer, autoimmune and viral diseases.

     

    We’re proud of our team of 350+ Atarians co-located by design in South San Francisco (corporate headquarters) and Southern California (R&D and manufacturing headquarters in the northwest Los Angeles area) with a newly-established European headquarters in Zug, Switzerland. Atara also has a R&D site in the Denver, Colorado area and an office in New York City. Our Southern California hub is anchored by a new 90,000 sq. ft., state-of-the-art Atara T-Cell Operations and Manufacturing (ATOM) facility in Thousand Oaks, California.

    Our mission – “Transform the lives of patients with serious medical conditions through pioneering science, teamwork and expertise.”

     

    Visit www.atarabio.com to learn more.

    Atara Bio is an equal opportunity employer and makes employment decisions on the basis of merit and other lawful factors. In accordance with applicable law, the Company prohibits discrimination based on race, color, religion, creed, sex, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity, expression or dysphoria, marital status, age, national origin or ancestry, physical or mental disability, medical condition, genetic information, veteran status, caregiver status, sexual orientation, transgender status or any other classification protected by federal, state or local laws or because of the individual’s association with a member of a protected group or connection to an organization or group related to a protected group.

    We comply with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Atara Bio in the United States.
      

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