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- ...Position Summary The Associate Director of CMC Regulatory Affairs provides support for all CMC regulatory activities related to the ongoing development, registration, and life-cycle management of RYTELO (imetelstat) and other potential future development product candidates...SuggestedFull timeFor contractorsLocal areaRemote workFlexible hoursAfternoon shiftEarly shift
Geron
Foster, CA23 hours ago - ...fulfil their aspirations. Join Gilead and help create possible, together. **Job Description** We are seeking an Associate Director, Regulatory Affairs CMC candidate to sit at our Foster City, CA site. **Responsibilities:** + The CMC Regulatory Affairs Associate Director...SuggestedFor contractorsLocal areaWorldwide
- ...done, and have fun, seriously. POSITION SUMMARY The Associate Director, Global Regulatory Affairs provides management of all aspects of assigned... ...project managers, Regulatory Labelling and Regulatory CMC, oversees the development of content and format for regulatory...SuggestedFull timeFor contractorsOdd jobLocal areaRelocation2 days per week
Mirum Pharmaceuticals, Inc.
Foster, CA23 hours ago - ...it done, and have fun, seriously. POSITION SUMMARY The Associate Director, Global Regulatory Affairs provides management of all aspects of assigned regulatory... ...project managers, Regulatory Labelling and Regulatory CMC, oversees the development of content and format for...SuggestedContract workFor contractorsFor subcontractorOdd jobWork at officeLocal areaRelocation2 days per week
- ..., developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description Regulatory Affairs Labeling is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across...SuggestedFull time
Gilead
Foster, CA23 hours ago - ...aspirations. Join Gilead and help create possible, together. **Job Description** Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional...SuggestedFor contractorsLocal areaWorldwide
- ...Description:_** BeOne is seeking an experienced and energetic regulatory professional to manage, evaluate, and complete regulatory projects... ...development of strategies, planning, drafting, and managing CMC-related regulatory submissions and HA interactions to meet the...Suggested
$110k - $132k
...threatening illnesses worldwide. Responsibilities include leading all CMC regulatory activities for assigned projects in line with ICH and... ...'s degree and 12+ years of experience in CMC Regulatory Affairs or 10+ years with an advanced degree, proven track record in...SuggestedFull timeWorldwideGilead Sciences, Inc.
San Mateo, CA20 days ago- **General Description:** BeiGene is seeking an experienced and instrumental regulatory professional to lead US biologics regulatory CMC team. This individual leads biologics regulatory CMC team based in US, partners with the counter-part based in China and cross-functional...Suggested
$78.13 - $93.75 per hour
...include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions. The Director, CMC Regulatory Affairs for Biologics is responsible for defining regulatory strategy for one or more molecules in the Biologics portfolio. This...SuggestedFull timeGilead Sciences, Inc.
San Mateo, CAa month ago- Join to apply for the CMC Regulatory Affairs Manager role at Katalyst CRO 13 hours ago Be among the first 25 applicants Join to apply for... ...Compliance Redwood City, CA $190,000.00-$220,000.00 3 weeks ago Associate Director of Regulatory Affairs Sr Regulatory Affairs Specialist (...SuggestedFull timeLocal areaRemote work
- Associate Director, Ethics & Compliance Advisor, Kite Cell Therapy Associate Director, Ethics & Compliance Advisor, Kite Cell Therapy United... ...related to interactions between commercial, medical affairs and market access. Participate in activity reviews consistent...SuggestedFull timePart timeFor contractorsLocal areaWorldwide
- Associate Director/Director of CMC Chemistry Location: South San Francisco, CA Position: Full-Time GenEdit... ...strategy, planning, and execution; provide regulatory documentation for all phases of... ..., clinical operations, regulatory affairs, quality, IP) to ensure CMC and program...SuggestedFull timeContract workWork experience placement
- ...in May 2024 and has received Fast Track designation from the FDA for the HARMONi trial. Role Overview The Senior Manager, Regulatory Affairs CMC, provides strategic guidance on Chemistry, Manufacturing, and Controls (CMC) for assigned products, managing regulatory CMC...SuggestedFull time
- ...PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single... ...investigational therapy that is not approved by any regulatory authority in Summit’s license... ...of Role: The Senior Manager, Regulatory Affairs CMC, is responsible for providing regulatory...SuggestedWork at office
- ...Director / Senior Director, Regulatory Affairs About Soleno Therapeutics Inc Soleno Therapeutics, Inc., based in... ...clearance of regulatory submissions associated with assigned projects consistent... ...to other functional areas (i.e., CMC, nonclinical, and clinical) for product...Full timeWork at officeLocal area
Soleno Therapeutics Inc
Redwood City, CA23 hours ago - ...-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule... ...therapy that is not approved by any regulatory authority in Summit’s license... .... ? Overview of Role: The Senior Director of CMC Strategy Development & Delivery will be...Full time
Summit Therapeutics Sub, Inc.
Menlo Park, CA3 days ago $67.71 - $81.25 per hour
...an audit advisory role with cross-functional involvement with U.S. and international finance teams and business partners. The Associate Director, SOX Compliance and Controls key area of responsibility include: design of key controls (business processes, interfaces, and...Full timeWork experience placementGilead Sciences, Inc.
San Mateo, CAa month ago- ...and help create possible, together. **Job Description** The Associate Director- QA Compliance, will report to the Director of Supplier Management... ...and clinical manufacturing platform(s) of current regulatory agency requirements and trends and develop and report on the...Contract workFor contractorsLocal areaWorldwide
- ...Marketing, and Operations to enable innovation while mitigating regulatory risk. The team is focused on embedding compliance into the... ...guidance, scalable processes, and proactive risk management. As the Associate Compliance Manager at Upstart, you will play a key role in...Remote work
