Senior Regulatory Affairs Scientific Leader

Summary: Our client, a clinical stage biopharmaceutical company based in California, is seeking an experienced and highly motivated, hands-on regulatory affairs leader to join their team. The successful candidate will be responsible for developing and implementing effective regulatory strategies to support the development of innovative cell...

Director/Senior Director, Regulatory Affairs – Irvine or Valencia Position summary: Plans, executes, and oversees daily activities associated with Global Regulatory Affairs. Primary responsibilities include guidance and mentoring of Regulatory staff and acting as Regulatory leader in the Medical, Legal and Regulatory Review process including review,...

The Director, Regulatory Affairs’ primary responsibility is to lead the Regulatory Affairs team in developing and implementing regulatory strategies and procedures. This role will lead regulatory strategy and submissions and provide regulatory guidance to the research and development teams during product development to ensure compliance with regulatory...

About Allogene: Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of...

Job Description Purpose: AbbVie is dedicated to delivering a consistent stream of innovative, safe, and effective quality medicines and products that solve serious health issues and have a remarkable impact on people’s lives. As a quality organization in research & development, R&D Quality Assurance (RDQA) is committed to driving quality excellence...

Job Description   Description     The Manager Regulatory Affairs represents US regulatory affairs for device development projects. Executes US regulatory strategic plans and provides guidance to Global Regulatory Lead (GRL) and project team. Plans and prepares complex regulatory submission documents primarily for US regulatory filings. Utilizing...

POSITION SUMMARY The primary responsibility of the Senior Regulatory Affairs Specialist is to manage and perform regulatory submissions for local and worldwide regulatory agencies. The Sr. RAS is also responsible for ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product...

Job Description Description   The Sr Manager Regulatory Affairs represents US regulatory affairs for device development projects. Responsible for development, communication, and execution of US regulatory strategic plans to Global Regulatory Lead (GRL) and project team. Plans and prepares (or oversees) complex regulatory submission documents primarily...

Job Description The Manager, Regulatory Affairs In Vitro Diagnostics and Companion Diagnostics works with internal and external partners to develop and implement global regulatory strategies for In Vitro Diagnostics (IVD)/Companion Diagnostics (CDx) to support business objectives. Supports regulatory objectives for the management of IVD/CDx...

Job Description Key Responsibilities   Responsible for providing regulatory strategy & support for global development. Responsible for supporting teams & efforts around major filing activities & Regulatory Health Authority (RHA) interactions & meetings, attending & providing regulatory support to other departments, project teams & committees. Organize...

Job Description Purpose The Asset Strategy Leader is an experienced and established leader with the ability to influence across multiple functions and levels within Abbvie who serves as the matrix leader with overall accountability for an asset from discovery to end of life cycle.  He / she guides and directs the creation and execution of a comprehensive...

Overview: What you can expect!    Find joy in serving others with IEHP! We welcome you to join us in “healing and inspiring the human spirit” and to pivot from a “job” opportunity to an authentic experience!   Under the direction of the Manager, Regulatory Affairs, the Analyst I - Regulatory Affairs (Policy & Communications) has a general...

With a robust set of core principles and a well-defined roadmap for sustained expansion, the company is seeking a CMC Regulatory Professional. The ideal candidate will possess:Offering regulatory guidance and assistance product manufacturing, emphasizing Chemistry, Manufacturing, and Controls (CMC) for approved NADA and ANADA products.Aid in executing...

Candle Media is seeking an experienced and versatile Vice President, Business Affairs to join our team. This individual will handle a diverse range of business affairs matters related to the development, production, co-production, licensing, and exploitation of unscripted and scripted programming (film and series) for Candle Media’s live action divisions,...

Job Description Manages the design and implementation of one or more clinical development programs in support of an overall Product Development Plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business operations, and emerging issues. Oversees project-related...

CorDx, a thriving biotechnology company, is seeking a Regulatory Coordinator to join our team. In this role, you will assist in the planning and execution of regulatory compliance activities. You will analyze and interpret regulations and guidelines to ensure company compliance and organize necessary documentation. The ideal candidate will be detail-oriented...

Seeking a Pharmaceutical Manufacturing Operations Workstream Lead to support the supply chain/quality teamResponsibilities • Assess and review current practices, advising on appropriate strategies to correct compliance gaps through intermediation controls and/or sustainable corrective/preventive actions. • Working with regulatory affairs to understand,...

Seeking a Pharmaceutical Manufacturing Operations Workstream Lead to support the supply chain/quality teamResponsibilities • Assess and review current practices, advising on appropriate strategies to correct compliance gaps through intermediation controls and/or sustainable corrective/preventive actions. • Working with regulatory affairs to...

Seeking Supply Chain Workforce Lead to assist with the company's Remediation Consent Decree and CMC programs to ensure the improvement initiatives are delivered on time. ******Please do not apply if you do not have experience with Regulatory Agency interactions specific to Pharmaceuticals (inspections, response, Warning Letters, Consent Decrees, etc.)******...

Seeking Supply Chain Workforce Lead to assist with the company’s Remediation Consent Decree and CMC programs to ensure the improvement initiatives are delivered on time. ******Please do not apply if you do not have experience with Regulatory Agency interactions specific to Pharmaceuticals (inspections, response, Warning Letters, Consent Decrees,...