SME Lead Regulatory Clinical RD Quality Manufacturing

Vice President of Quality and Regulatory Affairs San Francisco Bay Area (Hybrid) Our client is a cutting edge CAR-T who novel approach dramatically decreases the time and cost associated with manufacturing. This is a newly created position allowing you to get in on the ground floor and eventually build a team beneath you as their indications advance in...

Job DescriptionJob DescriptionSalary: Excellis Health Solutions, LLC, an NNIT Group Company, is a global strategic management consulting services firm, based in New Hope, PA, England, Belgium and Denmark.  An industry leader in supply chain, with a focus in Pharmaceuticals and Life Sciences and a specific niche in serialization, we offer a multitude of...

Job Description Job Description Salary: Excellis Health Solutions, LLC, an NNIT Group Company, is a global strategic management consulting services firm, based in New Hope, PA, England, Belgium and Denmark. An industry leader in supply chain, with a focus in Pharmaceuticals and Life Sciences and a specific niche in serialization, we offer a multitude of...

**SUMMARY**:The Regulatory QC Specialist is responsible for ensuring research compliance with protocols, federal regulations, industry guidelines and company Standard Operating Procedures. This position requires ongoing knowledge of GCP/ICH guidelines and the federal regulations related to conducting clinical trials. **ESSENTIAL DUTIES AND RESPONSIBILITIES...

Responsibilities: Provide strategic insight to the GRT regarding product development, and serve as Regulatory contributor to partner teams (eg, study execution teams, clinical development team etc.) as appropriate In collaboration with regional regulatory representatives, ensure that feedback from global Health Authorities is incorporated into the global...

Responsibilities: Provide strategic insight to the GRT regarding product development, and serve as Regulatory contributor to partner teams (eg, study execution teams, clinical development team etc.) as appropriate In collaboration with regional regulatory representatives, ensure that feedback from global Health Authorities is incorporated into the...

Job Description 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...

My client is a clinical-stage biopharmaceutical company focused on developing innovative therapies for rare diseases. They are currently seeking a skilled regulatory professional to join their growing team as Director/ Sr. Director CMC Regulatory Affairs. This role will involve hands-on development and implementation of regulatory strategies for CMC aspects...

Company Location: Bay Area Comp: 150K-220K Position Reports to: VP of Regulatory and Quality Director of Regulatory Affairs -San Francisco We are seeking a highly motivated and experienced Senior Director of Regulatory Affairs for a Medical Device Orthopedic Portfolio. This person will lead interactions with regulatory agencies globally and help develop &...

Work Location Corporate Headquarters (South San Francisco, CA) – Hybrid Position Summary Annexon Biosciences seeks a Quality Assurance (QA) Director/Senior Director to lead the company's clinical Quality Assurance (cQA) program. The incumbent will assist in the development of quality systems to ensure clinical trials are conducted in accordance with...

**Company Description** **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...

Job SummaryThe Living Therapeutics Initiative seeks a highly motivated Regulatory Affairs Senior Manager to manage the regulatory affairs, author and assemble IND applications, and help manage FIH studies advancing UCSF-developed cellular therapy candidates. The successful candidate will work in a dynamic academic environment, working across various...

Work Location Corporate Headquarters (South San Francisco, CA) – Hybrid Position Summary Annexon Biosciences seeks a Quality Assurance (QA) Director/Senior Director to lead the company's clinical Quality Assurance (cQA) program. The incumbent will assist in the development of quality systems to ensure clinical trials are conducted in accordance with...

Company DescriptionAt Andromeda Surgical, we are developing autonomous robots with the goal of making surgical procedures safer, easier, and more efficient. We are starting with a urologic procedure that has superior outcomes but a steep learning curve that has limited its adoption. Our mission is to elevate every surgeon to world expert level, empowering...

Why Patients Need You Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through...

Why Patients Need You Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through...

Vice President of Quality and Regulatory Affairs Our client is a cutting edge CAR-T who novel approach dramatically decreases the time and cost associated with manufacturing. This is a newly created position allowing you to get in on the ground floor and eventually build a team beneath you as their indications advance in development. If you are looking...

I'm working with a leading Class III medical device company dedicated to improving patient outcomes through innovative medical technologies. Our commitment to excellence and quality is at the forefront of everything we do. We are seeking a highly skilled and experienced Director of Quality Assurance to join our team and lead our quality efforts. Position...

Job DescriptionJob DescriptionWho we are Abdera Therapeutics Inc. is a precision oncology company developing next-generation targeted radiation therapies- one of the most cutting-edge and highly promising areas of drug development. The company is built on a proprietary modular technology platform optimized for the delivery of radioisotopes to selectively...

We are seeking a highly motivated collaborative Director of Quality Assurance for our South San Francisco location to develop, establish, implement and maintain a phase appropriate cGMP Quality management system for the Cell & Gene Therapy operations to support pre-clinical and clinical manufacturing. This individual will be responsible to lead and grow the...