Senior Manager – Regulatory Affairs CMC - San Francisco, CA

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 ...

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

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 ...

Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy ...

· Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monothera ...

Gilead is creating a healthier world for all people by tackling diseases such as HIV, viral hepatitis and cancer working relentlessly to develop therapies that help improve lives. · We continue to fight against the world's biggest health challenges our mission requires collaborat ...

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 ...

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

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 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. · In 2012, we received FDA a ...

Provide Regulatory Affairs CMC (RA CMC) expertise for global commercial and development projects. · Develop strategic approaches to enable successful health authority submissions and communications. · ...

+ Provide Regulatory Affairs CMC (RA CMC) expertise for global commercial and development projects. · + Develop strategic approaches to enable successful health authority submissions and communications. Work closely with cross-functional project teams on the content of US inves ...

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. ...

· Company Description · ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients' lives by Overcoming Resistance In Cancer. ORIC's clinical stage product candidates include (1) ORIC-944, an allosteric inhibitor of the polycomb repressive ...

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. · ...

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 ...

· 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 ...

· 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 ...

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 ...