Sr Manager, Regulatory Affairs CMC - Foster City, CA

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 ...

· 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 ...

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. ...

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. · ...

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

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

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, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators. · ...

The CMC Regulatory Affairs Project Manager will be responsible for tracking the status of key filings for clinical and commercial programs for all global markets. · ...

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 ...

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 ...

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 ...

This position supports the preparation review and submission of CMC sections for U.S and global regulatory filings INDs/CTAs amendments and BLAs/MAAs. · ...

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

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 ...

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 ...

Olema Oncology está dedicada al desarrollo mejorado de medicamentos para cáncer de seno y más allá. Nuestro programa líder actualmente en desarrollo para cáncer metastático con potencial blockbuster como monoterapia e en combinación en cáncer metastático ER+/HER2- · Fearlessmente ...