Manager, Regulatory Affairs

2 days ago

Santa Monica, United States Neogene Therapeutics Full time

At AstraZeneca's Oncology R&D division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference and have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs.

Position Summary

The Manager CMC Regulatory Affairs is responsible for supporting the development and successful performance of the CMC regulatory strategy for the innovative pipeline of early and late-stage T cell therapies. This position is hybrid and reports to the Sr. Director, CMC Regulatory Affairs.

Responsibilities

  • Interpret global regulations and guidance to identify risks and provide input for guidance to cross functional product teams.
  • Partner with cross-functional stakeholders to deliver regulatory dossiers (e.g. CMC component(s) of IND / IMPD / Master Files, amendments, annual reports) and health authority interaction briefing documents. Manage and maintain regulatory dossiers as required throughout the product development lifecycle.
  • Provide review and compilation and ensure that submission documents and correspondence are of the highest quality in terms of content, organization, clarity, and accuracy.
  • Represent CMC regulatory affairs on product teams and in health authority interactions.
  • Provide regulatory assessments for manufacturing changes and quality compliance and participate in technical risk assessment exercises.
  • Support the development and maintenance of regulatory templates, best practices, and procedures.
  • Perform other responsibilities.

Supervisory Responsibilities

  • Support hiring, leading and managing workflow.

Education and Experience

  • BA/BS degree in life sciences required, advanced degree preferred (PhD,MS, PharmD).
  • Experience of 8+ years with BS/BA; 6+ years with MS/MA or MBA; 5+ years with PhD.
  • Prior experience in cell/gene therapy.
  • In depth knowledge of global CMC regulations and understanding of evolving challenges and health authority expectations for cell therapies.
  • Experience in IND, IMPD, BLA, MAA filings.

When we put unexpected teams in the same room, we fuel bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

The annual base salary for this position ranges from $126,000 to $174,000. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related experience. If hired, employee will be in an "at-will position" and we reserve the right to modify base salary (and any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Benefits

  • Short-term incentive bonus opportunity
  • Equity-based long-term incentive program
  • 401(k) plan
  • Paid vacation and holidays; paid leaves
  • Health benefits including medical, prescription drug, dental, and vision coverage.

#LI-Hybrid

DE&I Statement

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

RequiredPreferredJob Industries
  • Other

  • Cell Therapy Regulatory Affairs Manager

    2 days ago

    Santa Monica, California, United States Neogene Therapeutics Full time

    About the RoleWe are seeking a highly skilled Cell Therapy Regulatory Affairs Manager to support the development and successful performance of our CMC regulatory strategy for innovative pipeline products.Key ResponsibilitiesInterpret global regulations and guidance to identify risks, providing input for cross-functional product teams.Partner with...

  • Senior Manager Regulatory Affairs

    3 weeks ago

    Santa Ana, United States PrimeGen US Full time

    PrimeGen US Inc. 2917 Daimler Street, Santa Ana, California 92705 Company DescriptionPrimeGen US is a pioneering biotechnology company dedicated to advancing stem cell research and developing groundbreaking cell therapies. We’re translating innovative discoveries into clinical solutions for acute and chronic inflammatory diseases. Our proprietary...

  • Senior Manager Regulatory Affairs

    3 weeks ago

    santa ana, United States PrimeGen US Full time

    PrimeGen US Inc. 2917 Daimler Street, Santa Ana, California 92705 Company DescriptionPrimeGen US is a pioneering biotechnology company dedicated to advancing stem cell research and developing groundbreaking cell therapies. We’re translating innovative discoveries into clinical solutions for acute and chronic inflammatory diseases. Our proprietary...

  • Senior Manager Regulatory Affairs

    4 weeks ago

    Santa Ana, United States PrimeGen US Full time

    PrimeGen US Inc. 2917 Daimler Street, Santa Ana, California 92705 Company DescriptionPrimeGen US is a pioneering biotechnology company dedicated to advancing stem cell research and developing groundbreaking cell therapies. We’re translating innovative discoveries into clinical solutions for acute and chronic inflammatory diseases. Our proprietary...

  • Associate Director, Regulatory Affairs

    2 days ago

    Santa Monica, United States Neogene Therapeutics Full time

    At AstraZeneca's Oncology R&D division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a...

  • Regulatory Affairs Strategist

    2 days ago

    Santa Clara, California, United States Collabera Full time

    Job OpportunityWe are seeking a highly skilled Regulatory Affairs Strategist to join our team at Collabera, a leading Global Digital Solutions Company.About the RoleThe successful candidate will be responsible for defining and implementing regulatory strategies and priorities in conjunction with management, peers, commercial, and affiliate personnel. This is...

  • Regulatory Affairs Professional

    6 days ago

    Santa Clara, California, United States Abbott Laboratories Full time

    About Abbott LaboratoriesAbbott is a global healthcare leader that empowers individuals to live their best lives. Our diverse portfolio of innovative technologies and solutions spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and pharmaceuticals.OverviewWe are committed to delivering...

  • Regulatory Affairs Specialist II

    2 weeks ago

    Santa Clarita, California, United States Boston Scientific Full time

    About the Position:As a Regulatory Affairs Specialist II at Boston Scientific, you will play a crucial role in ensuring the company's products meet regulatory requirements worldwide. This is a hybrid position that requires minimum three days of office work per week, with a preferred location in Valencia, CA, and flexibility to be located in other US BSC...

  • Regulatory Affairs Senior Manager

    2 weeks ago

    Santa Rosa, California, United States Medtronic Full time

    About the RoleWe are seeking an experienced and highly motivated Senior Manager of Regulatory Affairs to play a crucial role in the development and execution of global regulatory strategies for innovative transcatheter valve technologies.Key ResponsibilitiesOversight of multiple team members working on innovative programs from concept design to market...

  • Senior Manager, Regulatory Affairs

    5 months ago

    Santa Rosa, United States Medtronic Full time

    Senior Manager, Regulatory Affairs - Structural Heart & Aortic (hybrid) The Structural Heart and Aortic integrated operating unit offers minimally invasive approaches to restore proper structure and function of the heart and the aorta. We focus on the transcatheter replacement or repair of the four heart valves—aortic, pulmonic, mitral, tricuspid—and...

  • Regulatory Affairs Analyst

    3 weeks ago

    Santa Clara, United States Select Source International Full time

    Job DescriptionJob DescriptionTittle: Regulatory Specialist IILocation: Santa Clara California 95054• 2 years regulatory experience preferably with medical devices:• Knowledge of regulations and standards medical devices.• Education: BS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etc.•...

  • Principal Regulatory Affairs Specialist

    19 hours ago

    Santa Clarita, United States huMannity Medtec Full time

    At HuMannity Medtec, we pioneer life-enhancing medical technologies for under met healthcare needs. Come join our team of engineers, scientists and medical device experts who are inspired to develop innovative solutions for tomorrow's challenges. If you'd like to join a high-reward, truly inspiring environment with an experienced, diverse team working at...

  • Principal Regulatory Affairs Specialist

    3 months ago

    santa clarita, United States huMannity Medtec Full time

    At HuMannity Medtec, we pioneer life-enhancing medical technologies for under met healthcare needs. Come join our team of engineers, scientists and medical device experts who are inspired to develop innovative solutions for tomorrow’s challenges. If you’d like to join a high-reward, truly inspiring environment with an experienced, diverse team working at...

  • Principal Regulatory Affairs Specialist

    3 months ago

    santa clarita, United States huMannity Medtec Full time

    At HuMannity Medtec, we pioneer life-enhancing medical technologies for under met healthcare needs. Come join our team of engineers, scientists and medical device experts who are inspired to develop innovative solutions for tomorrow’s challenges. If you’d like to join a high-reward, truly inspiring environment with an experienced, diverse team working at...

  • Principal Regulatory Affairs Specialist

    3 months ago

    Santa Clarita, United States huMannity Medtec Full time

    At HuMannity Medtec, we pioneer life-enhancing medical technologies for under met healthcare needs. Come join our team of engineers, scientists and medical device experts who are inspired to develop innovative solutions for tomorrow’s challenges. If you’d like to join a high-reward, truly inspiring environment with an experienced, diverse team working at...

  • Principal Regulatory Affairs Specialist

    2 months ago

    Santa Clarita, United States huMannity Medtec Full time

    At HuMannity Medtec, we pioneer life-enhancing medical technologies for under met healthcare needs. Come join our team of engineers, scientists and medical device experts who are inspired to develop innovative solutions for tomorrow’s challenges. If you’d like to join a high-reward, truly inspiring environment with an experienced, diverse team working at...

  • Regulatory Affairs Project Leader

    2 months ago

    Santa Clara, United States Collabera Full time

    Job DescriptionJob Description·         Education: Bachelor's degree required, Master’s degree preferred·         Experience: Minimum of 3 years of Regulatory Affairs experience·         Skills: Knowledge of US and/or Canadian regulations or with EU and other international medical device regulations relating to product and/or...

  • Principal Regulatory Affairs Specialist

    2 weeks ago

    Santa Clarita, United States huMannity Medtec Full time

    At HuMannity Medtec, we pioneer life-enhancing medical technologies for under met healthcare needs. Come join our team of engineers, scientists and medical device experts who are inspired to develop innovative solutions for tomorrow’s challenges. If you’d like to join a high-reward, truly inspiring environment with an experienced, diverse team working at...

  • Principal Regulatory Affairs Specialist

    2 weeks ago

    Santa Clarita, United States huMannity Medtec Full time

    At HuMannity Medtec, we pioneer life-enhancing medical technologies for under met healthcare needs. Come join our team of engineers, scientists and medical device experts who are inspired to develop innovative solutions for tomorrow’s challenges. If you’d like to join a high-reward, truly inspiring environment with an experienced, diverse team working at...

  • Regulatory Affairs Project Lead Professional

    1 day ago

    Santa Clara, California, United States Collabera Full time

    Job OverviewThis position is a highly visible role that plays a key part in the company's regulatory strategy and priorities.ResponsibilitiesAssists in defining and implementing regulatory strategies in conjunction with management, peers, commercial, and affiliate personnel.Communicates issues to management through project management tracking and issue...