Senior Regulatory Affairs Specialist

Senior Director, Regulatory Affairs (Generalist) Remote Position for West Coast-based candidates, frequent travel to Bay Area required Meet is partnering with a late stage pediatric rare disease startup looking for a high-level Regulatory Affairs professional to join their team. This position will be reporting into the SVP of Regulatory Affairs and will be...

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...

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...

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,...

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...

Hays's recently been engaged with a Biotech Company for the search of a Vice President, Head of Regulatory Affairs in the Boston Area. - Full time Role - Role in the Boston Area. (Open to discuss if it's East Coast Based) - Reporting to the CMO of the company. Requirements: • Bachelor’s degree in a scientific discipline; Graduate degree (Ph.D....

Are you passionate about revolutionizing healthcare through innovative medical devices and cutting-edge AI technology? We are seeking a dynamic and experienced Director of Regulatory Affairs to join our team in the vibrant San Francisco Bay Area. If you thrive in a fast-paced environment, are driven by challenges, and are eager to make a significant impact...

Associate Director of Regulatory Affairs St. Louis, MO, USA Job Description Posted Monday, May 20, 2024 at 4:00 AM Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes around the...

Invenia Group is working with a rapidly expanding specialist manufacturer of scientific instrumentation to hire three director-level Medical Science Liaisons across the US (Scientific Affairs – Drug Development – West Coast). The company manufactures specialist proteomic instrumentation, kits and services used across a wide range of Biomarker /...

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,...

Title: Senior Medical Director, Clinical Development Description: The Senior Medical Director, Clinical Development is a vital contributor to clinical development programs, overseeing study-specific activities, collaborating with cross-functional teams, and supporting regulatory activities. Responsibilities include protocol design, data analysis,...

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...

Position Tile: Vice President of Market Access - Consultancy background needed The Vice President of Market Access is a senior leadership role responsible for developing and executing market access strategies to optimize product reimbursement, coverage, and overall market success. This position requires a deep understanding of the healthcare landscape,...

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.)******...

Title: Senior Medical Director, Clinical Development Description: The Senior Medical Director, Clinical Development is a vital contributor to clinical development programs, overseeing study-specific activities, collaborating with cross-functional teams, and supporting regulatory activities. Responsibilities include protocol design, data analysis,...

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,...

Our company culture is focused on helping our employees enable innovation by building breakthroughs together. How? We focus every day on building the foundation for tomorrow and creating a workplace that embraces differences, values flexibility, and is aligned to our purpose-driven and future-focused work. We offer a highly collaborative, caring team...

Position Tile: Vice President of Market Access - Consultancy background needed Location: United States Overview: The Vice President of Market Access is a senior leadership role responsible for developing and executing market access strategies to optimize product reimbursement, coverage, and overall market success. This position requires a deep...

DescriptionProvidence is calling a Senior Charge Description Master Specialist who will work remotely within our footprint states, AK, CA, OR, WA, TX, NM, or MT.As a member of the PSJH System Revenue Integrity Chargemaster (RICDM) Dept. team, the Senior CDM Specialist shall ensure that the Chargemaster (CDM) is consistent with all coding and billing...

Jobs in Structural Biology and Related Fields FIB-SEM Specialist/Senior Scientist Caltech, California, United States The Senior Scientist will maintain the FIB-SEM microscope, train new users, and develop workflows to streamline the data processing of cellular cryo-electron tomography. Interested candidates should submit a CV with the contact information of...