Global CMC Regulatory Director — Strategy & Leadership
Scorpion Therapeutics
Scorpion Therapeutics is seeking a Director, Regulatory CMC to lead global CMC strategies across clinical development, approvals, and lifecycle management. You will guide cross-functional teams, interface with agencies, and ensure compliance with regulatory requirements across regions. The role requires ~10 years in CMC Regulatory Affairs with leadership experience, a life-science degree, and strong collaboration skills. Domestic and international travel may be required. #J-18808-Ljbffr Scorpion Therapeutics
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- 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
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- 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,...Suggested
- 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
- 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
- Vir Biotechnology, Inc. is seeking a Director of Regulatory CMC to lead regulatory strategy for clinical development and commercialization. This role, based in San Francisco, requires a strategic thinker with 10+ years in pharmaceutical product development, adept in regulatory...
- 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...
- ...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...
- 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...
- 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...
- 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...
$170k - $230k
...Title: AssociateDirector, Regulatory Strategy Reports To: Executive Director, Regulatory... ...with guidance from senior leadership Demonstrated ability... ...authorities (FDA, EMA, and global agencies) Review... ...functional teams (Clinical, CMC, Nonclinical, Quality)...Full time- 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 Francisco. The... ...various departments to ensure compliance with CMC regulatory strategies for oncology products. The anticipated salary range is...- 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...
- Corvus Pharmaceutical, a clinical-stage biopharmaceutical company, is seeking a Director of Regulatory Affairs CMC reporting to the VP of Regulatory Affairs to lead global CMC regulatory strategies for clinical-stage small molecule programs. This role partners with CMC,...
- ...located in Brisbane, California, seeks a Senior Director of Regulatory Affairs to lead global regulatory strategies for the Annexon portfolio. You will guide regulatory... ...FDA and EMA, while coordinating with Clinical, CMC, and Quality teams. You will mentor regulatory staff...
$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$275k - $280k
...breakthroughs.Position Description:The Director of Regulatory CMC will lead the development and execution of global CMC regulatory strategies for our pipeline of small molecules and... ...cross-functional stakeholders and senior leadership and externally with CMOs and regulatory...- 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-...
- Novotech is seeking an Associate Director/Director of Workforce Planning to define and lead the global strategy, operating model, and governance for scalable, data-driven resourcing across the organization. This leadership role partners with executive teams to align capacity...
- Responsibilities Provide strategic PKDM-BA leadership for small molecule discovery... ...Lead PKDM-BA contributions to regulatory submissions, including INDs, NDAs, and interactions with global health authorities. Define and execute scientific strategies that support candidate...
- ...Medicines in San Francisco is looking for an Associate Director, CMC Regulatory to lead the execution of regulatory strategies for clinical development and lifecycle... ...collaboration with various teams to ensure compliance with global regulatory requirements. The ideal candidate...
$245k - $285k
...leading and managing the regulatory affairs within CMC function. This includes developing... ...leading regulatory CMC strategies and activities for a... ...cell therapy product on a global basis. The successful candidate... ...knowledge, experience and leadership in interpretation of...Contract work$258k - $320k
...has secured partnerships with leading global biopharmaceutical companies, generating... ...Responsible for leading the global CMC regulatory strategy and execution for both small molecule... ...with health authorities. Demonstrated leadership success as a people manager with experience...Work at officeWorldwideRelocation package- Department/Group: Regulatory Affairs Location: South... ...Affairs, the Director of Regulatory Affairs CMC will serve as a key... ...developing and executing global Chemistry,... ...Controls (CMC) regulatory strategies for clinical-stage... ...Strong cross-functional leadership and influencing...Full time
$260k - $295k
...seeking a motivated Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to be responsible... ...of regulatory strategies and submissions related... ...products in the US and globally. The incumbent will be... ...of the Tech Ops leadership team to keep CMC strategy...Full timeWork at officeLocal area2 days per week
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