Regulatory Submissions Manager
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.
This position will be responsible for logistics, preparation, quality check, and delivery of regulatory submissions in accordance with agency requirements and company standards. Acts as direct liaison with Regulatory Affairs staff and contributing departments to facilitate effective management of submissions.
Reports to: Associate Director, Regulatory Operations
Location: Westlake Village (Los Angeles area), CA
- Manages all aspects related to the preparation, tracking, compilation, publishing and technical quality control of all assigned regulatory submissions.
- Assist and/or train others on software tools used to educate authors on publishing policies and procedures. Provides functional and technical guidance to more junior colleagues in the Regulatory Operations Department.
- Establishment of process, procedures and best practices (WINs and SOPs) to supporting publishing activities.
- Serves as primary point of contact for publishing and supports processes for compiling global electronic submissions.
- Responsible for all aspects of publishing submissions and/or submission components for internal review and signoff, and for submission to regulatory authorities. This includes all operational tasks associated with or in support of authoring (formatting, editing, reviewing), publishing, production (paper and electronic).
- Formats daily regulatory submission documents ensuring that documentation meets Atara’s submission-ready standards under limited supervision.
- Demonstrates expertise and provides technical assistance for formatting regulatory submissions verifying and applying appropriate formatting.
- Ensure completion of high-quality submissions, following regulatory guidelines and internal processes within
- Ensure adherence to internal standards and processes, as well as Health Authority Requirements.
- Lead and promote current electronic initiatives in moving the company forward with electronic submissions and electronic archives.
- Prepare interpretative analyses of key regulatory guidance documents related to submissions. Interpret electronic submissions regulations. Develop and implement submission strategies (from operations perspective). Develop templates, processes, procedures to ensure compliance with regulations, and tools critical to compiling electronic submissions.
- Serve as Regulatory Operations team leader, collaborating with Regulatory Affairs staff and contributing functional areas to assure adequate prioritization, scheduling, preparation and dispatch of regulatory submissions.
- Provide accurate regulatory operations guidance and information to project and submission teams.
- Identifies resources and technologies as needed to support submission activities and to resolve identified issues and risks.
- Advise and direct implementation of the current RIM environment related to submission planning, preparation, assembly, dispatch and/or archiving.
- Leverage the current RIM system (Veeva) to create reports (i.e., Safety Reports, Planned and Submissions, Submissions Binder reports).
Skills and Abilities:
- Must be able and willing to work in a high-visibility, fast-paced environment while handling multiple priorities. Must be flexible, detail-oriented, and possess excellent analytical and problem-solving skills.
- Knowledge of MS Word Templates, Their Function, and Use MS Word Macros.
- Adobe Acrobat Expert.
- Working knowledge of Adobe Acrobat PDF formatting, advanced features such as OCR & Bookmarking.
- Shows strong initiative and drive. Must be an organized self-starter who is able to anticipate departmental needs.
- Proficient in establishing priorities and executing project plans.
- Ability to solve problems independently.
- Strong technical knowledge/understanding of publishing requirements/document placement within the XML.
- Knowledgeable in U.S. eCTD structure and requirements as well as submission requirements for all submission types in the applicable region(s).
- Experience with electronic document management software (e.g. Documentum), principles of information systems, and related technology are
- Advanced skills in MS Word, MS Excel, MS PowerPoint, and Adobe Acrobat are required.
- Experienced in electronic publishing software and advanced PDF-processing
- Experienced with records and/or document management standards.
- Excellent interpersonal and communication skills are essential. Ability to work successfully within a cross-functional team.
- Must be able to interact, communicate and present technical information to individuals at all levels of the organization.
Education and Professional Experience:
- Bachelor's degree or higher in a relevant technical or scientific field is required.
- 7 years of experience with regulatory submissions publishing is required.
- Working knowledge of Agency regulations and industry standards pertaining to regulatory operations is essential.
- Demonstrated understanding of the drug development process is highly preferred.
Subject to extended periods of sitting and standing, vision to monitor and moderate noise levels. Work is performed in an office environment.
Travel: Travel is not frequently required (<10%)
More About Atara Bio
Now in our sixth year, we’re proud of our team of 260+ 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.
One mission – “Transform the lives of patients with serious medical conditions through pioneering science, teamwork and expertise” – and a singular vision – “Cell therapy treatment for every patient, any time – provide inspiration and direction for all of us.”
The Company's off-the-shelf, allogeneic T-cells are bioengineered from donors with healthy immune function and allow for rapid delivery from inventory to patients without a requirement for pretreatment. Atara's T-cell immunotherapies are designed to precisely recognize and eliminate cancerous or diseased cells without affecting normal, healthy cells.
Atara's most advanced T-cell immunotherapy in development, tabelecleucel, or tab-cel™ (formerly known as ATA129), is being developed for the treatment of patients with Epstein-Barr virus (EBV) associated post-transplant lymphoproliferative disorder (EBV+ PTLD) who have failed rituximab, as well as other EBV-associated hematologic and solid tumors, including nasopharyngeal carcinoma (NPC). Tab-cel™ is in Phase 3 clinical development for the treatment of EBV+ PTLD following an allogeneic hematopoietic cell transplant (MATCH study) or solid organ transplant (ALLELE study).
Atara is also developing off-the-shelf, allogeneic ATA188 and autologous ATA190 T-cell immunotherapies using a complementary targeted antigen recognition technology for specific EBV antigens believed to be important for the potential treatment of multiple sclerosis (MS). A Phase 1 clinical study of autologous ATA190 in patients with progressive MS is ongoing. Atara is also advancing a Phase 1 clinical study of ATA188 in patients with progressive or relapsing-remitting MS across clinical sites in the United States and Australia. Atara's clinical pipeline also includes ATA520 targeting Wilms Tumor 1 (WT1) and ATA230 directed against cytomegalovirus (CMV).
Working at Atara Bio
People at Atara Bio are high integrity, roll-up-your-sleeves, get-it-done types who are keenly committed to putting patients first, advancing medical care and doing so with demonstrated urgency. At their core Atarians are people who work well with others and are “team-centric”, have purposeful curiosity and can’t wait to save patient lives. And similar to other biotech companies who have so many accomplished people, we expect humility (we are a “low hubris” sort of place), flexibility, respect, teamwork, good judgment and getting the most out of any dollar we spend. We also expect to enjoy the journey (and each other) as we move forward with a shared responsibility to teach and to learn from what we do and from our teammates.
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