CMC Regulatory Strategy Director — Global Compliance Leadership
ORIC Pharmaceuticals, Inc.
ORIC Pharmaceuticals, Inc. is seeking a Senior Director/Director, CMC Regulatory Affairs to lead global CMC regulatory strategies and documentation for oncology programs. Based in South San Francisco, you will partner with Regulatory Affairs, Quality, and Clinical teams to ensure compliant INDs, CTAs, NDAs, and MAAs. You will drive preparation of Module 2/3, IMPD, and post-submission activities, manage timelines, and mentor a regulatory team in a fast-paced, collaborative environment in the #J-18808-Ljbffr ORIC Pharmaceuticals, Inc.
- Scorpion Therapeutics is seeking a Director, Regulatory CMC to lead global CMC strategies across clinical development,... ...interface with agencies, and ensure compliance with regulatory requirements... ...in CMC Regulatory Affairs with leadership experience, a life-science degree...Suggested
- Zai Lab is seeking a global CMC regulatory leader to head regulatory strategy for small molecules and biologics across all development stages. You will oversee... ...manage end-to-end dossier preparation, ensuring compliance and scientific rigor. You will lead a team of CMC...SuggestedWorldwide
- ACADIA Pharmaceuticals Inc. seeks a Director, Regulatory CMC to lead global regulatory CMC strategies for small molecule programs from development through commercialization. You will advance development, regulatory submissions, and lifecycle management across key regions...Suggested
- ...Princeton, New Jersey, is seeking a regulatory affairs leader to develop and manage Global and US regulatory activities for... ...will formulate US regulatory strategy, lead global submissions, and... ...requires strong cross-functional leadership and effective communication. #J...Suggested
- Corvus Pharmaceuticals, Inc. in South San Francisco, CA, is seeking a Director of Regulatory Affairs CMC to lead global regulatory strategies for small molecule programs from IND/CTA through NDA/MAA and lifecycle management. Reporting to the VP of Regulatory Affairs, the...Suggested
- Meet Life Sciences is seeking a Senior Director of Regulatory CMC to lead global regulatory strategies for clinical development and commercial products. The role requires deep CMC expertise across small molecules and biologics, exceptional negotiation with authorities,...
- Marea Therapeutics seeks a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to lead regulatory strategies and submissions for the manufacturing of our products in the US and globally. The incumbent will oversee Regulatory CMC aspects of product...
- Kardigan is seeking a Senior Director, CMC Regulatory to lead regulatory strategies and interactions for late-stage programs focused on cardiovascular therapies... ...with FDA, EMA, and ICH guidelines, plus a track record of successful global #J-18808-Ljbffr Socket.dev
$220k - $270k
ORIC Pharmaceuticals is seeking a Senior Director/Director of CMC Regulatory Affairs to lead CMC regulatory activities in South San... ...collaboration across various departments to ensure compliance with CMC regulatory strategies for oncology products. The anticipated salary...- Marea Therapeutics is seeking a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to shape regulatory strategies for manufacturing across the US and global markets. The role reports to the Executive Director of Regulatory Affairs and will own CMC...Work at office2 days per week
- Marea 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 reports to the Executive Director of Regulatory Affairs and requires...Full time
- Kardigan seeks a Senior Director, CMC Regulatory to lead the development and execution of CMC regulatory strategies driving global submissions and interactions with health authorities. This role reports to the Head of CMC Regulatory and is based in South San Francisco,...
$275k - $280k
...Position Description:The Director of Regulatory CMC will lead the development and execution of global CMC regulatory strategies for our pipeline of... ...technical consistency and compliance across all stages of the... ...stakeholders and senior leadership and externally with CMOs...- Enigma Search is looking for a Director of Regulatory Affairs to spearhead regulatory strategies in South San Francisco. The ideal candidate will possess a Master’s... ...therapies and ensuring clear communication with global health authorities. The candidate should be self-...
$258k - $320k
...partnerships with leading global biopharmaceutical companies... ...Responsible for leading the global CMC regulatory strategy and execution for both... ...integrity, and regulatory compliance across all product... ...authorities. Demonstrated leadership success as a people manager...Work at officeWorldwideRelocation package$245k - $285k
...leading and managing the regulatory affairs within CMC function. This... ...leading regulatory CMC strategies and activities for a... ...product on a global basis. The successful... ...regulatory phase-appropriate compliance of gene and cell... ..., experience and leadership in interpretation of...Contract work- ...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... ...collaborates with Tech Ops leadership and external partners. This...Full time
- Scorpion Therapeutics is seeking an senior Regulatory Affairs leader to shape global regulatory strategies for immunology and inflammation programs. You will work with Regulatory leadership, development teams, and CROs to deliver robust development plans and submissions...
- ...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 monoclonal antibodies, ensuring compliance throughout the product lifecycle. The ideal...
$260k - $295k
...motivated Senior Director, Regulatory Chemistry,... ..., and Controls (CMC) to be responsible... ...development of regulatory strategies and submissions... ...in the US and globally. The incumbent... ...of the Tech Ops leadership team to keep CMC... ...are in compliance with applicable...Full timeWork at officeLocal area2 days per week$275k - $280k
...About the Job: The Senior Director of Regulatory CMC will lead the development and execution of global CMC regulatory strategies to accelerate clinical... ...approvals and maintain compliance for clinical and commercial... ...stakeholders and senior leadership, CMOs, and regulatory...Local areaRelocationRelocation package3 days per week- Department/Group: Regulatory Affairs... ...Regulatory Affairs, the Director of Regulatory Affairs CMC will serve as a... ...and executing global Chemistry,... ...CMC) regulatory strategies for clinical-stage... ..., and compliance with global regulatory... ...cross-functional leadership and influencing...Full time
- AbbVie is seeking an Associate Director Regulatory Affairs, CMC to lead regulatory strategies and submissions for complex products. You will collaborate with R&D, Operations and Global Regulatory teams to enable first-pass approvals and ensure compliant content for INDs...
- Nurix Therapeutics, Inc. is seeking a Director/ Senior Director of Regulatory Affairs (Strategy, Oncology - Solid Tumors) to develop and execute global regulatory strategy and lead high-quality submissions. You will partner with SVP Regulatory Affairs and cross-functional...
- Calico Life Sciences is looking for a Regulatory Director in South San Francisco to develop and implement innovative regulatory strategies, ensuring compliance with health authority guidelines. The role requires collaboration with various teams, overseeing regulatory submissions...
$169k - $338k
...Segment: Home OfficeLead executive communications strategy for Walmart’s Global Tech and Product leadership—crafting speeches, presentations, messaging, and social... ...EVP, AI Acceleration, Product & Design. As Senior Director, Executive Communications and Strategy, you’ll...Full timeTemporary workPart timeWorldwide- ...governments, retailers, restaurants and global businesses who rely on us to save lives,... ...architect and lead the global sourcing strategy for one of the world’s most innovative robotics... ....This is a highly visible executive leadership role requiring close partnership with...Long term contractContract workLocal areaWorldwide
$280k - $310k
...SUMMARYThe Senior Director, Regulatory Affairs CMC is a position requiring... ...and operational leadership, and who will ensure... ...all regulatory CMC strategies to support market... ...CMC commitments, and global development... ...Opportunity (EEO) and to compliance with all Federal, State...Local area$157.59k - $203.94k
...DescriptionJOB DESCRIPTIONThe Senior Manager, CMC Regulatory Affairs - Combination Products and... ...development and implementation of global regulatory strategy and is accountable for execution of... ...and model Gilead’s Core Values, Leadership Commitments, and People Leader...Full timeFor contractorsLocal area$210.38k - $272.25k
...possible, together.Job DescriptionThe Director, CMC Regulatory Affairs - Combination Products... ...for setting and leading global CMC regulatory strategy for complex, high-impact device and... ...communication, presentation, and leadership skillsABOUT GILEADGilead Sciences...Full timeFor contractorsLocal area
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