Senior Director Regulatory Affairs CMC
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 supports all CMC regulatory affairs activities for the company’s products and research, provides CMC regulatory input for regulatory strategies and RA CMC leadership within regulatory and on cross-functional CMC teams.
Reports to Vice President Regulatory Affairs CMC
Location Westlake Village, (northwest Los Angeles area), CA
- Leads the development of competitive regulatory strategies.
- Provides strategic and 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.
- Manages 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.
- Serves as a liaison between the regulatory authorities and the company on CMC issues, successfully prepare teams, lead regulatory agency meetings.
- Manages 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.
- Provides updates on strategic global regulatory intelligence, such as new regulations, guidance, ODACs, competitive product applications and approvals, etc.
- Identifies and drafts necessary SOPs and/or Work Instructions for Regulatory Affairs.
- Contributes to the creation and maintenance of a Target Product Profile and Company Core Data Sheet.
- Provides 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.
- Leads interdepartmental team review and approval of submission document deliverables including: distribute drafts, attend review meetings, and incorporate revisions.
- Collaborates with Regulatory Operations or publishing vendors to ensure that Atara’s practices are in conformance with the latest health authority and industry submission standards.
- Ensures logging, tracking and filing of correspondence with regulatory authorities and ensuring that no commitment remains unduly outstanding.
- Assists the teams with change control assessment in order to ensure that they meet regulatory requirements.
- Hires, leads, mentors and develops a team of direct reports.
- Performs 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 leadership and management skills.
- Strong communication skills (e.g., clear and concise), team player, proven negotiation skills.
- Ability to manage and motivate staff.
- Demonstrated experience with global development, registration and post-approval submissions.
- 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.
- Experience with hiring, coaching, developing and leading a team.
- Extensive knowledge of US and international regulatory requirements.
- Proficient in pertinent software & tools.
- Strong collaboration and cross-functional partnership building.
- Role model for Atara’s Values of patients first, innovation teamwork, community and mindset.
Education and Professional Experience
- Minimum of a Bachelor's degree, preferably in Sciences/Health Related Sciences, from an accredited college or university.
- 15 or more years of related pharmaceutical or biopharmaceutical industry experience, with at least 10 of those years directly in regulatory affairs.
- Must be knowledgeable in industry trends for study reports and global dossier preparation (e.g., IND/CTA/NDA/NDS), including electronic document submissions (i.e., eCTD).
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.