This position 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: Associate Director, Regulatory Affairs CMC
Location: Thousand Oaks (northwest Los Angeles area), CA.
Relocation Assistance Provided
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.
Travel: Travel may be required (up to 25%).
Subject to extended periods of sitting and standing, vision to monitor and moderate noise levels. Work is performed in an office environment.
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.
Education and Professional Experience:
Minimum of a Bachelor's degree or foreign equivilant in Regulatory Affairs or a closely related field.
Approximately 4-8 years of related pharmaceutical or biopharmaceutical industry experience, with at least 3 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).
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.