Sr. Associate, Regulatory Affairs
The Associate/Senior Associate Regulatory Affairs position supports regulatory affairs activities, including but not limited to assembling and preparing inputs for regulatory submissions, participation in regulatory project teams, collecting and summarizing regulatory intelligence, and managing the compilation and review of all submissions for quality and completeness as well as archiving regulatory correspondences.
Reports to: Director or Senior Director in Regulatory Affairs
Location: Thousand Oaks, CA
Travel: Less than 10%, not expected
- Collaborate across various Regulatory functions (Reg Strategy, Reg CMC, Reg Ops) to support submission execution:
- Support timely preparation of documents for inclusion in US and ex-US regulatory submissions (i.e: 1572, annual compliance updates, cover letters, agency forms, etc.)
- Ensure the quality, accuracy, completeness, and compliance of submission documents and the overall content relative to internal and external standards
- Log and track various regulatory deliverables and health authority correspondence to ensure regulatory compliance and health authority inspection-readiness
- Provide administrative support within the Veeva system, including archiving and document management
- Perform regulatory research as directed
- Work across Regulatory functions to produce functional standard operating procedures, work instructions, and best practice guides as directed
Skills and Abilities
- A team player with the ability to communicate and interact effectively across all levels, disciplines, and regions
- Knowledge of applicable regulatory agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc).
- Highly organized; strong time and project management skills
- Able to prioritize, multi-task, and work in a fast-paced and demanding environment
- Attention to detail a must; proclivity to produce high-quality deliverables a must
- Takes ownership of a given assignment; resourceful and proactive in consulting team members and other department representatives for information or guidance, as needed
- Understands and interprets data/information and its practical application
- A person who operates effectively in a smaller company and works well across teams within a matrixed organization
- Working knowledge of manufacturing research and development. CMC regulatory experience, and/or knowledge of cellular therapies manufacturing, and quality development would be an advantage.
- Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution
Education and Professional Experience
- Minimum Bachelor’s degree (MS preferred) in Sciences/Health Related field from an accredited college or university
- The candidate must have a minimum 2+years of experience in the Biopharma industry preferably with experience in regulatory (Operations, CMC or Clinical Reg).
- Baseline knowledge of pharmaceutical biologics drug development, clinical research, regulatory affairs, and medical terminology
- Strong knowledge with MS Office applications, MS Project, MS Teams, SharePoint and Document Management System.
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 400+ 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) facility.
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.”
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.
Learn more here
Job posted: 2020-11-05