Director, Regulatory Affairs CMC - Redwood City, California, United States

Lead regulatory affairs activities for assigned programs consistent with global regulatory requirements. · ...

Corcept is leading the way in cortisol modulators research. · Lead preparation of CMC regulatory documents; · ...

Corcept is leading the way in the research and development of cortisol modulators. · ...

· Exec Director Regulatory Affairs/CMC · Allakos Inc. is a dynamic clinical-stage biopharmaceutical company developing first-in-class antibody-based therapeutics to treat allergic and inflammatory diseases. · The Executive Director, CMC Regulatory Affairs is responsible for deve ...

We are seeking an experienced and strategic Associate Director/Director of CMC Regulatory Affairs to lead and execute regulatory activities for our ECO Synthesis platform and associated manufacturing activities. · ...

We are seeking an experienced and strategic Associate Director/Director of CMC Regulatory Affairs to lead and execute regulatory activities for our ECO Synthesis platform and associated manufacturing activities. · - Develop and implement CMC regulatory strategies for the ECO Synt ...

We are seeking an experienced and strategic Associate Director/Director of CMC Regulatory Affairs to lead and execute regulatory activities for our ECO Synthesis platform and associated manufacturing activities. · Develop and implement CMC regulatory strategies for the ECO Synthe ...

We are seeking an experienced and strategic Associate Director/Director of CMC Regulatory Affairs to lead and execute regulatory activities for our ECO Synthesis platform and associated manufacturing activities. · Develop and implement CMC regulatory strategies for the ECO Synthe ...

The Senior Director Regulatory Affairs CMC is a position requiring a strong leader who will provide strategic and operational leadership ensuring the effectiveness of the Regulatory Affairs CMC team. The role involves overseeing all regulatory CMC strategies to support market app ...

The Senior Director Regulatory Affairs CMC is a position requiring a strong leader who will provide strategic and operational leadership, and who will ensure the effectiveness of the Regulatory Affairs CMC team within the Regulatory Affairs department and across the organization. ...

We're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. · Coordi ...

The CMC Regulatory Affairs Project Manager is responsible for supporting the planning, coordination, and execution of CMC regulatory activities across global clinical and commercial programs. · ...

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the glob ...

· MISSION · Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experi ...

· Company Description · ObjectWin provides global workforce solutions to meet current and future business demands of our customers. Our services include, various workforce solutions, SOW based projects and fulltime resource deployments. We serve our customers both nationally and ...

Regulatory Affairs Manager CMC · San Fran - Hybrid/Onsite · We are partnering with a well-established global pharmaceutical and combination product company that has been operating for over 20 years and is currently expanding its pharmaceutical division. As part of this growth, th ...

Regulatory Affairs Manager CMC · San Fran - Hybrid/Onsite · We are partnering with a well-established global pharmaceutical and combination product company that has been operating for over 20 years and is currently expanding its pharmaceutical division. As part of this growth, th ...

This is a Regulatory Affairs Manager position supporting preparation review submission CMC sections U.S global regulatory filings INDs CTAs amendments BLAs MAAs coordinating internal stakeholders gather technical information ensure accuracy consistency CMC documentation developin ...

Provide Regulatory Affairs CMC expertise and leadership for global commercial and development projects. · Provide regulatory strategies, appropriate for the stage of product development, to PSC designed to maximize chances of successful and expedient registration with appropriate ...

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the glob ...