Vice President, Global CMC Regulatory - San Francisco

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

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 ...

As Senior Manager, Regulatory CMC Lead, you will provide regulatory CMC expertise to support assigned projects and products contribute to global CMC regulatory strategy and where appropriate lead regulatory submissions and related strategic activities. · You will be part of a dyn ...

Sr Manager Regulatory CMC Lead will provide regulatory CMC expertise to support assigned projects and products. You will be part of a dynamic team collaborating closely with the CMC Global Regulatory Lead and key stakeholders. · ...

As a Senior Manager, Regulatory CMC Lead, you will provide regulatory CMC expertise to support assigned projects and products. · ...

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 ...

+The Regulatory CMC Project Manager is a client-facing consulting role responsible for providing project management support to Regulatory Chemistry, Manufacturing, and Controls (CMC) programs for pharmaceutical, biotechnology, and/or medical device clients across the product deve ...

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 ...

IDEAYA Biosciences is seeking an experienced Senior Director Regulatory CMC to support its therapeutic development programs. · Bachelor's degree in a Life Sciences discipline or equivalent. · Minimum of ten (10) years of experience in clinical regulatory and high potential for le ...

IDEAYA Biosciences is seeking an experienced leader to head Regulatory CMC. · The Senior Director, Regulatory Affairs CMC will support the CMC Regulatory Affairs function and be responsible for planning and executing the CMC regulatory strategies for IDEAYA's therapeutic developm ...

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 ...

As a new member of the Revolution Medicines team you will join other outstanding scientists in tireless commitment to patients with cancers harboring mutations in RAS signaling pathway The Opportunity This position is responsible for developing and implementing global CMC regulat ...

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. · ...

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

+Job summary · The Regulatory CMC Project Manager is a client-facing consulting role responsible for providing project management support to Regulatory Chemistry, Manufacturing, and Controls (CMC) programs for pharmaceutical, biotechnology, and/or medical device clients across th ...

This role provides PSC Regulatory expertise and leadership for biologics and Bioconjugates commercial and development projects. · Lead development of high quality, phase appropriate CMC-related submissions to regulatory authorities and regulatory affairs. · ...

This role provides PSC Regulatory expertise and leadership for biologics and Bioconjugates commercial and development projects. · Responsible and accountable for leading development of high-quality, phase appropriate regulatory sections and delivering documents to regulatory oper ...

+ 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 ...