Director/Senior Director, Regulatory Affairs CMC

Company: Atara Biotherapeutics, Inc
Location: Thousand Oaks
Posted on: January 10, 2022

Job Description:

Director/Senior Director, Regulatory Affairs CMC Job Locations US-CA-Thousand Oaks - US-CA-South San Francisco ID 2021-1821 Category Regulatory Affairs Type Regular Full-Time Job Description The Director/Senior Director, Regulatory Affairs supports all CMC regulatory affairs activities for the company's products and research, summarize regulatory intelligence, provides CMC regulatory input for regulatory submissions, and manages the compilation and review of CMC sections of all submissions for completeness and quality. Reports to VP, Regulatory Affairs CMC Location Thousand Oaks or South San Francisco, CA Travel May be required (up to 20%) Primary Responsibilities:

• Provide tactical support for the timely preparation, editing and review of submissions, including regulatory agency Meeting Requests and Briefing Documents, IND/CTA amendments, original Marketing Authorization Applications and their respective amendments/supplements.
• Manage assigned regulatory projects and closely collaborate with personnel from Clinical, Regulatory Operations, other scientific departments and external vendors to coordinate and implement submission strategy and content in a global clinical development environment.
• Provide updates on strategic global regulatory intelligence, such as new regulations, guidance, ODACs, competitive product applications and approvals, etc.
• Identify and draft necessary SOPs and/or Work Instructions for Regulatory Affairs.
• Contribute to the creation and maintenance of a Target Product Profile and Company Core Data Sheet.
• Provide US regulatory intelligence to project specific regulatory strategies, including scenarios for the earliest regulatory approvals possible as well as an assessment of risk for each of the various scenarios.
• Coordinate and manage regulatory submission documents (e.g., cover letters, Meeting Requests, Meeting Briefing Packages, etc.) to produce submission ready content (SRC).
• Manage the quality, accuracy, compliance with internal and external standards, and the timely production of submission documents using manual and electronic document management systems, as appropriate.
• Coordinate interdepartmental team review and approval of submission document deliverables including: distribute drafts, attend review meetings, and incorporate revisions.
• 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.
• Review documents in change control in order to ensure that they meet regulatory requirements.
• Perform other related duties as assigned. - Qualifications
  • Bachelor's degree in Regulatory Affairs or a scientific field. Master's degree preferred.
  • 10+ years of related pharmaceutical or biopharmaceutical industry experience, with at least 8 of those years directly in regulatory affairs.
  • Extensive knowledge of regulatory requirements.
  • Experience with cell and gene therapy products preferred.
  • 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).
  • Strong communication skills (e.g., clear and concise), team player, proven negotiation skills.
  • Ability to manage and motivate staff.
  • Strong understanding of pharmaceutical development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, project management, and medical terminology.
  • 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.
  • Able to take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary.
  • Able to understand and interpret data/information and its practical application. - More about Atara Bio We launched -Atara Biotherapeutics -in August 2012 to help patients with serious diseases and few therapeutic options. 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 550+ Atarians co-located by design in 4 different locations including South San Francisco (corporate headquarters), Thousand Oaks (R&D and manufacturing headquarters), Zug, Switzerland (european headquarters) and a R&D site in the Denver, Colorado area. 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.
    
    Our mission - "Transform the lives of patients with serious medical conditions through pioneering science, teamwork, and a commitment to excellence." Our vision - "T-Cell Immunotherapy for every patient, any time." Atara offers a competitive benefits packages that includes medical/dental/vision benefits, life and disability, retirement and stock program, as well as a generous paid time off and wellness plan that supports the well-being of our staff. Visit www.atarabio.com/careers 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. - - Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.

Keywords: Atara Biotherapeutics, Inc, Thousand Oaks , Director/Senior Director, Regulatory Affairs CMC, Executive , Thousand Oaks, California