CMC Regulatory Affairs Director - Lead, Global
$220k - $270kORIC Pharmaceuticals
ORIC Pharmaceuticals is seeking a Senior Director/Director of CMC Regulatory Affairs to lead CMC regulatory activities in South San Francisco. The ideal candidate will have over 10 years of experience in the pharmaceutical industry and excellent technical writing skills. This role requires collaboration across various departments to ensure compliance with CMC regulatory strategies for oncology products. The anticipated salary range is $220,000–$270,000 for Director and $250,000–$300,000 for Senior Director candidates. #J-18808-Ljbffr ORIC Pharmaceuticals
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...pathway. The Opportunity: The Senior Director, Molecule Global Regulatory Lead will develop and execute global... ...Clinical Development, Biometrics, and CMC to deliver high-quality global submissions... ...12+ years of regulatory affairs experience within the biotechnology...SuggestedFull timeLocal area$211k - $264k
...mutations in the RAS signaling pathway. The Opportunity The Director of Regulatory Affairs (Global Filing Lead) is accountable for driving preparation & execution... ...across Regulatory, Clinical, Biostatistics, CMC, Quality, Translational Medicine and Commercial. The...Full timeWork experience placementLocal area- Enigma Search is looking for a Director of Regulatory Affairs to spearhead regulatory strategies in South San Francisco. The ideal candidate will possess... ...-in-class therapies and ensuring clear communication with global health authorities. The candidate should be self-motivated...
- A leading biotechnology company in South San Francisco seeks a Director of Clinical Regulatory to oversee multiple clinical drug candidates and drive... ...role involves overseeing global Health Authority interactions... ...experience in regulatory affairs, strong strategic skills, and...
- Corvus Pharmaceuticals, a clinical-stage biopharma company, seeks a Director of Regulatory Affairs CMC to develop global CMC strategies for small molecules and lead regulatory submissions. This role partners with CMC, Technical Operations, Quality, and Clinical teams to...
- Erasca is seeking a Sr Manager/Assoc Director, CMC Regulatory Affairs to lead regulatory activities for IND/CTA development and ongoing trials. The role... ..., ensuring regulatory compliance, and coordinating global submissions. The ideal candidate will have 5+ years in...Remote job
$275k - $280k
...to devise interventions that enable people to lead longer and healthier lives. Calico’s highly innovative... ...medical breakthroughs.Position Description:The Director of Regulatory CMC will lead the development and execution of global CMC regulatory strategies for our pipeline of...$140k - $214k
...together every day. We lead with empathy, act with... ...a Senior Manager, Regulatory CMC to join an experienced... ...report to the Senior Director of Regulatory CMC and... ...activities in the US and globally to support development... ....Represent Regulatory Affairs on cross-functional project...Contract workFor contractorsFlexible hours- ...Therapeutics is seeking a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to shape regulatory... ...across the US and global markets. The role... ...Director of Regulatory Affairs and will own CMC submissions... .... The candidate will lead CMC strategy, manage regulatory...Work at office2 days per week
- ...South San Francisco, seeks a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to lead regulatory strategies and submissions for our US and global programs. The role reports to... ...Executive Director, Regulatory Affairs and collaborates across Tech Ops...
- Sentibio in South San Francisco seeks a regulatory affairs leader to drive CMC strategies for a complex cell therapy program. You will shape global regulatory CMC plans, coordinate type B/C/D meetings, and ensure alignment with agency expectations across the organization...
- ...Therapeutics, Inc. is seeking a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to lead regulatory strategies and submissions for US and global manufacturing programs. This role... ...Executive Director of Regulatory Affairs and requires strong strategic...Full time
- ...late-stage biopharmaceutical company in seeking a Senior Director, Regulatory Affairs, CMC. This lead CMC regulatory expert role partners with Regulatory... ...Technical Operations, and Development teams to drive global CMC strategy and execution through late-stage development...
- ...Pharmaceuticals Inc. in South San Francisco is seeking an Associate Director of CMC Program Management to lead end-to-end CMC strategies, cross-functional execution,... ..., and ability to navigate complex programs across regulatory and commercial #J-18808-Ljbffr ORIC Pharmaceuticals...
- A leading biopharmaceutical company in South San Francisco seeks a Director of Regulatory CMC. This pivotal role involves developing global regulatory strategies for a pipeline of small molecules and... ...extensive experience in Regulatory Affairs with a successful track record...
$220k - $270k
Senior Director/ Director, CMC Regulatory Affairs Full-time ORIC Pharmaceuticals is a clinical stage biopharmaceutical... .... This position is responsible for leading CMC regulatory activities and... ...regulatory strategies in compliance with global regulatory requirements for the...Full timeH1bCurrently hiring- ...Francisco is seeking a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to lead regulatory strategies for manufacturing... ...products in the US and globally. The role reports to the Executive Director, Regulatory Affairs and collaborates with Tech Ops...Full time
$175k - $205k
Sr Manager/Assoc Director, CMC Regulatory Affairs San Diego, CA, South San Francisco, CA or remote Erascais... ...of CMC Regulatory Affairs will lead and participate in regulatory activities... ...and support development of appropriate global regulatory filing strategies. Collaborate...Temporary workCasual workLocal areaRemote workWorldwideFlexible hours$245k - $285k
The successful candidate will be responsible for leading and managing the regulatory affairs within CMC function. This includes developing and leading regulatory... ...activities for a complex cell therapy product on a global basis. The successful candidate will ensure that all...Contract work- Nurix Therapeutics, Inc. is seeking a Director, Regulatory Affairs (Strategy, I&I) to join the Regulatory team in Brisbane, CA. This global lead role develops regulatory strategy for immunology and inflammation, guiding early development and lifecycle management, with...
- ...withcardioendocrinediseases. The company’s lead program, MAR001, is... ...a motivated Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to be responsible for... ...in the US and globally. The incumbent will be... ...Director, Regulatory Affairs and will be involved...Full timeWork at office2 days per week
$204k - $281k
About This Role:As the CMC Asset Lead, you will be an integral part of the PO&T Nephrology team, focusing on the development and launch of... ...commercial launch.Experience in alliance management, preferably global, and understanding of business contracts.Expertise in CMC,...Full timeTemporary workLocal area$280k - $310k
...fun, seriously.POSTION SUMMARYThe Senior Director, Regulatory Affairs CMC is a position requiring a strong leader who... ...applications, post-marketing CMC commitments, and global development programs across Mirum portfolio.Directly leads the regulatory CMC strategy for assigned...Local area$146.54k - $189.64k
...possible, together.Job DescriptionThe CMC Regulatory Affairs Manager is responsible for supporting the... ...of CMC regulatory activities across global clinical and commercial programs. This... ...tracking regulatory fileability risks, track. Lead meeting logistics and documentation,...Full timeFor contractorsLocal area$157.59k - $203.94k
...DescriptionJOB DESCRIPTIONThe Senior Manager, CMC Regulatory Affairs - Combination Products and Device is... ...the development and implementation of global regulatory strategy and is accountable... ...Affairs Combination Product and Device Lead for assigned device and combination...Full timeFor contractorsLocal area$195.5k - $272.5k
...motivated, self-driven and enthusiastic Director of Regulatory CMC accountable for ensuring all... ...paradigms and influence global Health Authorities. We are looking... ...functional groups and Regulatory Affairs department to plan and lead high quality regulatory submissions...Full timeWork at officeWork visa3 days per week
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