SantaBarbaraRecruiter Since 2001
the smart solution for Santa Barbara jobs

Director Regulatory Affairs- Companion Diagnostics

Company: Agilent
Location: Carpinteria
Posted on: April 3, 2021

Job Description:

Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek ---- so they can do what they do best: improve the world around us. Information about Agilent is available at . Be a part of the future of Precision Medicine! Our mission is to improve the human condition by bringing the power of precision medicine to labs, partners and patients globally. In the Companion Diagnostics Business (CDx), our team partners very closely with leading pharmaceutical companies to develop, manufacture and commercialize highly regulated medical devices which are critical for physicians to help select therapies for their patients. Become a part of a growing and dedicated team that does truly inspiring work in the field of Precision Medicine. Our employees are passionate about their contributions because there is a very direct connection to helping patients with cancer. This is an exciting opportunity to be part of a growing team with proven record of success in global registrations in Companion Diagnostics in the field of Oncology. In this role you will have opportunity to closely work with the group of approximately 20 Regulatory Affairs and Quality Design Assurance professionals, managing 3-6 direct reports. Staff members are located in US, China, Japan and EU. The successful candidate must be a strategic thinker, able to evaluate and act on various complex scenarios involving co-development programs of drug and diagnostics, with ability to manage aggressive timelines. Besides strong regulatory affairs expertise in IVD's, the successful candidate is also a strong people manager, able to work with the Director of this group to ensure all Regulatory Affairs and Quality Design Assurance systems are established, implemented, and maintained in accordance with applicable standards for the company. In this role, the ideal candidate

  • Works closely with CDx functional heads in establishing and implementing CDx business and strategic goals
  • Develops and implements strategies for timely submission and approval of regulatory submissions for Companion/Complementary Diagnostic products
  • Interacts and collaborates with pharmaceutical partners in drug and diagnostic co-development programs
  • Ensures the accurate and timely preparation of regulatory submissions and reporting in accordance with company goals, regulatory requirements and partnership contracts
  • Interacts with the FDA and other regulatory agencies in connection with submission, approvals, and audits
  • Participates in Joint Steering Committees and Joint Project Teams as the senior representative of regulatory affairs in the Companion Diagnostics division
  • Prepares and presents project status reports, strategy and initiatives to CDx leadership teams, Sr. DGG staff, as it relates to regulatory affairs
  • Works across Agilent DGG in formulating regulatory processes/procedures and shares best practices/knowledge with regulatory colleagues across Agilent
  • Stays abreast of global IVD regulations and guidance's, especially those relevant to Companion Diagnostics This is a remote role

Keywords: Agilent, Santa Barbara , Director Regulatory Affairs- Companion Diagnostics, Executive , Carpinteria, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Executive Jobs

Director of Human Resources
Description: Reports to br SVP Sales Marketing br Location: br Global Corporate HQ - West Hills, CA br br JOB DESCRIPTION br Summary/Objective br The Director of Human Resources is responsible for (more...)
Company: Electro Rent
Location: Canoga Park
Posted on: 04/13/2021

Account Manager (Strategic Communications)
Description: WE ARE RALLY br br RALLY is an issue-driven communications firm with a record of driving progress around complex political and social problems. Our firm was founded in California and over the past (more...)
Company: RALLY: a communications firm
Location: Los Angeles
Posted on: 04/13/2021

One Boeing Electronics Mechanical Manager
Description: Position Overview:Boeing Defense Space Security is seeking an Electronics Mechanical Manager K level - to manage-engineering teams-designing future generations of One Boeing electronics to join the Space (more...)
Company: BOEING
Location: Los Angeles
Posted on: 04/13/2021

Life Science Validation Project Manager (Design Group)
Description: About Us:Design Group operates from more than 45 offices in the United States and India, providing engineering, consulting and technical services for the world's leading companies in the food and beverage, (more...)
Company: Barry Wehmiller Design Group
Location: Los Angeles
Posted on: 04/13/2021

Director Product/Project Management (Remote)
Description: The role of Director of Product/Project Management will work collaboratively with corporate HQ teams to help oversee and manage defined product categories and execute retail and marketing business plans. (more...)
Company: Harbor Freight Tools
Location: Calabasas
Posted on: 04/13/2021

Senior Project Manager
Description: The Senior Project Manager is responsible for the overall direction, completion, and financial outcome for several small to medium projects or on one very large project. The Senior Project Manager leads (more...)
Company: Confidential
Location: Los Angeles
Posted on: 04/13/2021

Quality Assurance Manager
Description: Food Talent Solutions has partnered with a renowned food processor specializing in frozen prepared foods and cooked deli
Company: Food Talent Solutions
Location: Los Angeles
Posted on: 04/13/2021

Director HCP Marketing
Description: The Director HCP Marketing is a key member of the marketing team focused on internal readiness and execution for the successful launch of Arcutis' first product, Roflumilast, as well as multiple other (more...)
Company: Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT)
Location: Los Angeles
Posted on: 04/13/2021

Consulting Project Manager Utilities Operations Products (NMS / OMS)
Description: As a recognized authority and leading contributor, this project management professional, provides consistent innovative and high quality solution leadership. Responsible for guiding the successful implementation (more...)
Company: Oracle
Location: Encino
Posted on: 04/13/2021

Technical Project Manager Utilities Cloud Products PMO
Description: Manage the development and implementation process of a specific company product. Manage the development and implementation process of a specific company product involving departmental or cross-functional (more...)
Company: Oracle
Location: El Segundo
Posted on: 04/13/2021

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Santa Barbara RSS job feeds