Director/Senior Director, Regulatory Affairs CMC
Company: Atara Biotherapeutics, Inc
Location: Thousand Oaks
Posted on: January 10, 2022
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
- 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
- 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
- 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,
- 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
- 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
- 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
- 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
- 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)
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
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Keywords: Atara Biotherapeutics, Inc, Thousand Oaks , Director/Senior Director, Regulatory Affairs CMC, Executive , Thousand Oaks, California
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