Global CMC Regulatory Lead - Small Molecules
$302.01k - $390.83kDormont Manufacturing Co
Dormont Manufacturing Co in Foster City, California is looking for a seasoned regulatory affairs expert to lead global CMC regulatory strategies. The position requires a scientific degree and significant experience in small molecule development, regulatory strategies, and submissions to Health Authorities.
The ideal candidate will demonstrate strong leadership and strategic decision-making skills, ensuring compliance with global regulatory requirements while fostering partnerships within the organization. Comprehensive benefits, including a competitive salary range of $302,005 - $390,830, are offered.
#J-18808-Ljbffr$302.01k - $390.83k
...together. Job Description Lead CMC teams/ groups to support the CMC product and portfolio regulatory affairs goals and contribute to the development of global regulatory initiatives.... ...and cultural evolution of the Small Molecules organization while promoting development...RegulatoryFor contractorsLocal area$244k - $305k
...leader for the role of Senior Director, Global CMC Lead. The Senior Director, Global CMC Lead... ...development-stage and late-stage small molecule programs. This individual will partner... ...closely with CMC cross functional teams, Regulatory, Quality, Clinical Development, and external...RegulatoryFull timeLocal area$211k - $264k
Revolution Medicines is searching for a Director, Global CMC Regulatory in Redwood City, California. This strategic role includes developing global CMC regulatory strategies for marketing approvals and lifecycle management of oncology therapies. Candidates must have at...RegulatoryWorldwide$261k - $304.5k
## Senior Director, CMC Lead Product DevelopmentApplylocations: South... ...supply chain, CMC, quality, regulatory, program & portfolio... ...& Non-clinical Development; Global Supply Chain & Technical Operations... ...experience/skillsets: + Small molecule API, formulation development...Regulatory$211k - $264k
...pathway. The Opportunity: The Director, Global CMC Regulatory is a strategic leadership role... ...objectives. Responsibilities: Develop and lead execution of effective global CMC... ...for new chemical entities (NCEs) and small molecules, with proven ability to manage complex...RegulatoryWorldwide- ...lifespan. We’re hiring an experienced CMC Regulatory Lead to own the strategy and operations... ...builder and doer who can set clear, global CMC regulatory strategies and roll up... ...include both cell therapies and small molecules. Develop the regulatory CMC strategy...Regulatory
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...function in their South San Francisco office. The role involves managing global IP portfolios, collaborating with various teams, and implementing patent protection strategies for small molecule products. Ideal candidates should have a Ph.D. in Chemistry, at least 7 years...Work at office$294k - $367k
...execution-oriented leaders, Vice President, Global CMC Regulatory, reporting to SVP of Pharmaceutical... ...Manufacturing (PDM) Regulatory, to lead our global chemistry, manufacturing,... ....). The role requires expertise in small molecule pharmaceutical development and...RegulatoryFull timeLocal area$211k - $264k
...RAS signaling pathway. The Opportunity The Director of Regulatory Affairs (Global Filing Lead) is accountable for driving preparation & execution of global... ...across Regulatory, Clinical, Biostatistics, CMC, Quality, Translational Medicine and Commercial. The Director...RegulatoryFull timeWork experience placementLocal area$275k - $280k
...interventions that enable people to lead longer and healthier lives. Calico... ...Description : The Director of Regulatory CMC will lead the development and execution of global CMC regulatory strategies for our pipeline of small molecules and monoclonal antibodies to...Regulatory$186k - $233k
...hands-on Associate Director, CMC Regulatory who will be responsible for... ...submissions to support RevMed's global clinical trials, including... ...: Develop, lead, and implement global CMC regulatory... ...environment Experience with small molecules (NCEs) and managing complex...RegulatoryFull timeLocal area$165k - $195k
Initial Therapeutics, Inc. in South San Francisco is searching for a Regulatory Affairs expert. This role involves leading global regulatory activities and ensuring compliance for biopharmaceutical products. Candidates should have a Bachelor's degree in a scientific field...RegulatoryFlexible hours- ...in South San Francisco, is seeking a Senior Scientist to lead efforts in small molecule synthesis and process development. The ideal candidate will... ...with external partners, and ensuring compliance with regulatory standards. Join us in advancing novel therapeutics within...Regulatory
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Director - PKDM - Small Molecule Portfolio Strategy & LeadershipSkip to main... ...clinical development and regulatory submission. You will combine... ...proactive problem solving.* Lead PKDM-BA contributions to regulatory... ...NDAs, and interactions with global health authorities.* Define...RegulatoryFlexible hours- A leading biotechnology company in South San Francisco seeks a Director of Clinical Regulatory to oversee multiple clinical drug candidates and drive development as a regulatory... ...project lead. The role involves overseeing global Health Authority interactions, leading...Regulatory
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...the primary AD/QC scientist for our small molecule program, you will lead the analytical strategy for drug substance... ...closely with the Program Lead, CMC Lead, QA, and external CDMOs and... ...quality, support manufacturing and regulatory activities, and strengthen the analytical...RegulatoryFull timeFlexible hours$180k - $210.5k
...most complex biologics ever attempted to protect humankind. *LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first,... ...activities. This role develops and executes multi-product global regulatory CMC strategies for investigational products and leads the...RegulatoryRemote work$177.1k - $328.9k
Overview A Section Lead position for Specialized Analytics and Capabilities (Director... ...of complex biologics and small molecule impurities using advanced tools such as... ...Provide overarching MS strategy to ensure global regulatory alignment and direct response to health...RegulatoryLocal areaRelocation package$209k - $260k
...the Director Technical (CMC) Project Management... ...CMC Project Leadership Lead end‑to‑end CMC project... ...analytical, quality, regulatory, and supply chain activities... ...across a network of global CDMOs. Partner with... ...experience with small molecule and oral solid dosage...Regulatory$277.8k
...Opportunity The Expert Imaging Lead, Cardiovascular, Renal & Metabolism... ..., ensuring alignment with molecule and program goals, clinical and regulatory requirements, and enterprise innovation... ...engaging study management teams and global development stakeholders. You represent...RegulatoryLocal area$422k
...Denali Therapeutics Inc in South San Francisco seeks a leader in global regulatory affairs and quality to oversee compliance, product quality, and patient safety. The ideal candidate will have over 20 years of experience in biotechnology, including significant executive...Regulatory$210.38k - $272.25k
...create possible, together. Job Description The Director, Global MES Business Lead is a senior, business-facing leadership role accountable... ...meet global GMP, data integrity, validation, and regulatory expectations . Support health authority inspections, internal...RegulatoryFull timeFor contractorsLocal area- Revolution Medicines, based in Redwood City, CA, is looking for a Director of Regulatory Affairs to oversee global NDA/MAA filings for late-stage oncology therapies. The role includes managing cross-functional teams and ensuring regulatory compliance while providing actionable...Regulatory
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...Opportunity The Associate Director, Global Regulatory Affairs Project Management is... ...Regional Regulatory Science Leads to advance global regulatory strategies for assigned molecules across indications.... ...Clinical, Safety, Biostatistics, CMC / Pharmaceutical Development...RegulatoryWork at office$300k - $390k
...orally available, superior small molecule medicines that... ...financed by top‑tier global life sciences investors... ...pipeline and progress our lead obesity development... ...Partner with Quality and Regulatory to ensure GMP... ...cross‑functionally with CMC Development, Quality,...RegulatoryInterim role$158k - $198k
...responsible for developing and implementing global CMC regulatory strategies. The role involves... ...experience in CMC development of NCEs / small molecules with 3+ years of CMC regulatory experience. ~ Experience in leading CMC related global submissions (IND, IMPD...RegulatoryFull timeLocal area$215.54k - $260.82k
A leading biotechnology company is seeking an Associate Director, Clinical Regulatory in South San Francisco. This role requires developing regulatory strategies, overseeing global Health Authority interactions, and mentoring junior professionals. Candidates should have...Regulatory$171k - $223k
...seeks an experienced Associate Director, Clinical Regulatory in South San Francisco. The role focuses on leading regulatory strategy for development programs in neurodegenerative... ...diseases, overseeing interactions with global Health Authorities and mentoring junior staff....Regulatory
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