Regulatory Affairs Expert

Job Title: Regulatory Affairs Specialist - CMCNeurocrine Biosciences is seeking a highly skilled Regulatory Affairs Specialist - CMC to join our team. As a key member of our regulatory affairs team, you will be responsible for leading the development and execution of regulatory strategies for assigned commercial and development projects.Key...

At CorDx, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. This role will be responsible for assisting in the preparation, compilation, submission, and maintenance of regulatory filings and registrations, including DeNovo and 510(k) submissions for IVD products.The ideal candidate will have a strong understanding of regulatory...

About the Role:Dexcom is seeking a highly motivated and detail-oriented individual to join our Regulatory Affairs team as an Intern. As a Regulatory Affairs Specialist, you will play a critical role in preparing, submitting, and gaining regulatory approvals for our life-changing products, therapies, and customers around the world.Key...

Regulatory Affairs SpecialistAjinomoto Bio-Pharma is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for providing support for all internal and external regulatory-related activities.Key Responsibilities:Collaborate with internal team members to maintain compliance with...

Job Title: Regulatory Affairs LeaderCompany Description: Trebla Talent is a pioneering cell therapy biotech focused on developing innovative immunotherapies for cancer treatment.Role Description: As the Head of Regulatory Affairs, you will drive strategic regulatory decisions across the entire portfolio, leading a growing regulatory team and playing a key...

At CorDx, we are seeking a highly skilled Regulatory Coordinator to join our team. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring the compliance of our medical devices with regulatory requirements.Key Responsibilities:Assist in the preparation, compilation, and submission of regulatory filings and...

Job OverviewCorDx is a leading biotech organization dedicated to delivering innovative medical device solutions. We are seeking an experienced Associate Director of Regulatory Affairs to lead our regulatory submissions and ensure compliance with applicable regulations.This role will play a crucial part in the successful approval and launch of our medical...

Job Title: Director, Regulatory AffairsCodera is a life-sciences focused investment company that creates, acquires and finances companies that develop and commercialize pharmaceutical products. We are seeking a highly skilled Director, Regulatory Affairs to support the development and execution of domestic and international regulatory strategy for Codera.Key...

At Abbott Laboratories, we're seeking a highly skilled Regulatory Affairs Specialist II to join our team. As a key member of our Regulatory Affairs department, you'll play a critical role in ensuring compliance with US, EU, and international regulations and standards for our diagnostic products.Key Responsibilities:Provide regulatory support for diagnostic...

At DivIHN Integration Inc, we're seeking a skilled Regulatory Affairs Specialist to join our team. This is a unique opportunity to make a meaningful impact in the field of regulatory affairs.About the Role:This position will play a crucial role in coordinating change order reviews, allowing our full-time RA professionals to focus on key strategic...

Company Overview: Ignite Human Capital is dedicated to enhancing the lives of patients and families by developing safe, highly effective, and accessible allogeneic NK and macrophage cell therapies for the treatment of various serious diseases, including cancer.Position Overview: We are seeking an accomplished and dynamic Senior Director of Regulatory Affairs...

At Abbott Laboratories company, we are seeking a highly skilled Regulatory Affairs Specialist II to join our team. This role will be responsible for providing regulatory support for diagnostic product development and commercial products, ensuring compliance with US, EU, and international regulations and standards.Key Responsibilities:Reviews and approves...

Mantell Associates is partnering with a mid-size Biotech company specializing in Radiopharmaceuticals and Oncology. They seek a Regulatory Affairs expert to lead the Regulatory group, driving growth and hands-on involvement.Key Responsibilities:Lead and oversee the Regulatory Affairs team, including hiring, management, motivation, coaching, and...

Job SummaryThe Director/Senior Director, Regulatory Affairs will lead the development and execution of innovative CMC regulatory strategies to support the global development and commercialization of a drug/device combination product. This role requires dynamic leadership and direction to multi-disciplined project teams, working collaboratively with...

Job Title: Regulatory Affairs ExecutiveJob Summary:Electra Therapeutics, a clinical stage biotechnology company, is seeking a highly skilled Regulatory Affairs Executive to join their team. As a key member of the leadership team, this individual will be responsible for building and overseeing quality assurance and regulatory functions for the company.Key...

Job SummaryWe are seeking a highly skilled Regulatory Affairs Director to support Shell Energy's wholesale/retail trading/origination businesses and Shell Renewable and Energy Solutions related businesses through external advocacy for competitive markets, communicating regulatory changes and impacts of regulatory changes to commercial teams, conducting due...

Role SummaryVerizon is seeking a highly skilled Senior Manager, Regulatory and Government Affairs to join our team. In this role, you will be responsible for representing and advocating for Verizon's interests before state regulatory commissions and relevant state legislative policy committees in California and other states.Key ResponsibilitiesDevelop and...

Job OverviewIgnite Human Capital is seeking a seasoned Senior Director of Regulatory Affairs to spearhead regulatory strategies and activities concerning the development and approval of cell therapy products.This pivotal role will provide strategic leadership, ensuring compliance with global regulatory standards while supporting organizational objectives.Key...

About Dexcom's Summer Intern Program:Are you looking to spend your summer working with innovative technology and changing the lives of patients with diabetes? Dexcom's U.S. 12-week internship program provides an experience-driven program aimed at developing the next generation of talent. Our onsite, hybrid, and remote work models ensure that we can invite...

About the RoleWe are seeking a highly skilled Senior Regulatory Affairs Specialist to lead our advertising and promotion regulatory efforts. As a key member of our team, you will be responsible for ensuring compliance with FDA regulations and guidelines for commercial materials.Key Responsibilities:Lead cross-functional collaboration to ensure timely reviews...