Manager/Senior Manager Regulatory Affairs - CMC

Atara Biotherapeutics Thousand Oaks , CA 91360

Posted 6 months ago

Job Description:

Position Summary:

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

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.

Travel: Travel may be required (up to 25%).

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


Position Requirements:

  • 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 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.


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Regulatory Affairs Manager CMC

Amgen Inc.

Posted Yesterday

VIEW JOBS 12/12/2019 12:00:00 AM 2020-03-11T00:00 Career Category Regulatory Job Description Amgen is searching for a Regulatory Affairs Manager, CMC (Chemistry, Manufacturing and Controls). It is anticipated this person will work from the main corporate campus in Thousand Oaks, CA, however qualified candidates from the AMA and APR sites will also be considered. The Regulatory Affairs Manager, CMC will provide regulatory strategy for lifecycle management (Commercial) products, including determining regulatory reporting, and global filing requirements for post approval variations. The Manager will also facilitate communication of requirements and strategy to Process Development Team (PDT) in addition to the functional areas. The Manager will follow standard department and global marketing template processes to drive consistency across post approval programs. Serve as Regulatory CMC voice for product teams by providing the following services: * Define minimum regulatory filing requirements for post approval programs * Provide regulatory strategy through development of marketing application strategic plan and/or events * Global regulatory strategy * Development of post approval variations including maintenance of applications * Maintain product compliance through appropriate regulatory filings and activities * Support Change Management activities * Respond to regulatory agency questions * Facilitate agency interactions, including meeting preparation, meetings and briefing documents * Ensure alignment with variation master plans, develop global implementation requirements, and implement changes throughout product life-cycles * Liaise with other Functions in development, operations, and commercial to ensure alignment of global regulatory strategies, timing, execution and plans * Contribute to the Product Delivery Teams Variation Master Plan * Maintain information for Center dashboards; and collaborate with other Centers to ensure information alignment * Monitor and, as necessary, provide data to be entered into tracking systems (e.g., IMR) for department deliverables and ensure information is current * Participate as an active member of cross-functional teams including GRT, PDT, PQT, etc., as needed Basic Qualifications Doctorate Degree OR Master's Degree and 3 years of Regulatory CMC or related technical experience OR Bachelor's Degree and 5 years of Regulatory CMC or related technical experience OR Associates degree and 10 years of Regulatory CMC or related technical experience Preferred Qualifications * Degree in Life Science * Experience in manufacture, testing (QC/QA or clinical), process development or other related Pharmaceutical/Biotech industry * Regulatory CMC experience with small molecule and Biologic products * CMC-specific regulatory knowledge & experience Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission – to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. . Amgen Inc. Thousand Oaks CA

Manager/Senior Manager Regulatory Affairs - CMC

Atara Biotherapeutics