Senior Director, Regulatory Affairs CMC - Lead Submissions
Corcept Therapeutics
Corcept Therapeutics in Redwood City, California is seeking a Director of Regulatory Affairs CMC to lead the preparation of CMC regulatory documents from pre‑IND to marketing authorization across multiple therapeutic areas. This hybrid role requires oversight of a high-performing regulatory team and compliance with evolving regulations. The ideal candidate will have a scientific background along with 10+ years of experience in regulatory affairs and direct experience with major regulatory filings such as INDs and NDAs/MAAs. Strong leadership and communication skills are essential. #J-18808-Ljbffr
$280k - $310k
...Senior Director, Regulatory Affairs CMC Foster City Mirum Pharmaceuticals is a biopharmaceutical company... ...be responsible for all CMC-related submissions: strategic planning, execution, and... ...across Mirum portfolio. Directly leads the regulatory CMC strategy for...SeniorLocal area- A leading clinical-stage biotech company is seeking a Director/Senior Director for the Lirentelimab CMC team in Redwood City, CA. This role involves leading a cross-functional... ...capabilities, and experience in regulatory submissions. The position offers a competitive salary...Senior
$211k - $264k
...The Opportunity: The Director of Regulatory Affairs (US Filing Lead) is accountable for... ...Clinical, Biostatistics, CMC, Quality, Translational Medicine... ...development & regulatory submission activities for... ...outcomes and report progress to senior management. Drive and/...SuggestedFull timeWork experience placementLocal area$221k - $286k
...patients for generations to come. The Senior Director, Regulatory CMC - CAR T Cell Therapy provides... ...CMC regulatory strategies, leading complex submissions, managing lifecycle changes, and... ...Development, Quality, Global Regulatory Affairs, and external partners to enable...SeniorFor contractorsWork at officeLocal areaRemote workRelocationFlexible hours- Position: Director / Senior Director, Lirentelimab CMC Team Leader Location: Redwood City, CA... ..., business, quality, regulatory representatives who also... ...activities. Your Role: Lead a cross-functional CMC team... ...elements for regulatory submissions and consultations....Senior
$238.9k - $281.1k
...City, California. To learn more, visit Lead the preparation of CMC Regulatory documents from pre-IND to marketing authorization submissions in multiple therapeutic areas, molecules... ...of experience working in Regulatory Affairs in the biopharmaceutical industry Experienced...Full time3 days per week$238.9k - $281.1k
...Director, Regulatory Affairs CMC Redwood City, California, United States Lead the preparation of CMC regulatory documents from pre‑IND to marketing authorization submissions across multiple therapeutic areas, molecules, and regions. This hybrid role will be on‑site three...Full time3 days per week$158k - $198k
...developing and implementing global CMC regulatory strategies. The role... ...quality sections for regulatory submissions including initial submission... .... Provide updates to senior management on regulatory activities... .... ~ Experience in leading CMC related global submissions...SeniorFull timeLocal area- ...Position: Executive Director, Regulatory Affairs CMC Location: Redwood City, CA Job Id: 270-1156 # of Openings... ...of drug products. They will: Lead teams with regulatory CMC responsibility... ...CMC regulatory strategies for CTA submissions and marketing applications. This role...
- ...The Opportunity: Senior Manager of Regulatory Affairs Senior Manager of Regulatory Affairs will provide project... ..., preparation, coordination, and submission of regulatory documents to global National... ...include Clinical, Preclinical, or CMC content. Correspond and collaborate...Senior
$164k - $205k
...pathway. The Opportunity: The Senior Manager of Regulatory Affairs will provide project teams with... ...planning, preparation, coordination, and submission of regulatory documents to global... ...may include Clinical, Preclinical, or CMC content. Correspond and...SeniorFull timeLocal area$157.59k - $203.94k
...patients for generations to come. As a Senior Manager, CMC Regulatory Affairs for Biologics, at Gilead you will... ...of CMC regulatory (Biologics) submissions, and "right to operate" by maintaining... ...JOB DESCRIPTION CMC regulatory lead for a single or multiple products....SeniorFor contractorsWork experience placementLocal areaWorldwide- ...Director, Regulatory CMC (Hybrid – San Francisco Bay Area) We... ...Regulatory CMC will lead global CMC regulatory... ...interface between Regulatory Affairs, CMC, Quality,... ...IND/CTA, BLA, and NDA submissions. This is a hybrid... ...ability to influence senior stakeholders...
- ...biopharmaceutical company in Redwood City is seeking an Executive Director of Regulatory Affairs CMC to lead the regulatory strategy for drug products. The ideal... ...authorities to ensure compliance and optimize submission processes. Competitive salary based on experience. #J-...
$191.25k - $247.5k
...Director, Global Regulatory Affairs CMC At Gilead our pursuit of a healthier world for all people has yielded... ...vector–based products. This role leads the development, compilation, review... ..., Module 3) for global regulatory submissions, including clinical trial applications...Work at officeRemote workRelocationFlexible hoursShift work$244k - $305k
...development of global regulatory therapeutic area and product... ...therapeutic areas. Lead and mentor GRLs/Study... ...for regulatory submissions and governance communications... ...8 years in Regulatory Affairs including regulatory... ...and presenting to senior management. Proven ability...SeniorFull timeWork experience placementLocal area$180k - $210.5k
...protect humankind. *LEAD WITH HEART: Everyone leads... ...multi-product global regulatory CMC strategies for... ...filing of regulatory CMC submissions. Manages interactions... ...Pharmacy, Regulatory Affairs for Drugs, Biologics or... ...Reports to: Executive Director, CMC Regulatory Location...Remote work$186k - $233k
...strategic and hands-on Associate Director, CMC Regulatory who will be responsible for... ...CMC sections of regulatory submissions to support RevMed's global... ...: Develop, lead, and implement global CMC regulatory... ...in global CMC regulatory affairs. Experience in leading...Full timeLocal area$240k - $290k
..., and integrity. The Global Regulatory Lead is responsible for developing... ...leading to the creation and submission of Regulatory documents, e.g... .... May supervise Regulatory Affairs Associates. Consistently works... ...the base salary for the Director Global Regulatory Lead role...Local area- ...in Redwood City, is searching for a Director Global Regulatory Lead to manage regulatory strategies for... ...5 years of comprehensive regulatory affairs experience across major regions and... ...Responsibilities include leading regulatory submissions and developing strategic plans. The...
$182.07k - $235.62k
...come. As an Associate Director, CMC Regulatory Affairs for Biologics, at Gilead you... ...regulatory (Biologics) submissions, and "right to operate" by... ...you will be accountable for leading the interpretation and implementation... ...high level feedback to Senior CMC Management on points...For contractorsLocal areaWorldwide- ...Position Summary: The AD, Regulatory Affairs CMC, is responsible for developing... ...trial applications and other submissions which present CMC information. Author and lead CMC content for Health... ...Interacts with BeiGene employees and senior management. Interacts with...Contract workLocal area
$133.2k - $172.37k
...Kite Manager, Global Regulatory CMC Kite, as part of Gilead, is dedicated... ...for CMC regulatory submissions, lifecycle management, and change... ..., and Global Regulatory Affairs. Kite is transitioning from... ...Key Responsibilities Lead all operational and lifecycle...For contractorsWork at officeLocal areaRemote workRelocationFlexible hours$164k - $205k
...Opportunity: Revolution Medicines is seeking a Senior Manager, Commercial Regulatory Affairs to partner closely with the cross-functional teams to... ...products on MLR teams with oversight. Manage regulatory submissions of promotional materials as required (e.g., FDA Form...SeniorFull timeLocal areaRemote work- ...Planet Pharma Group is hiring a Senior Manager of Regulatory Affairs in Redwood City, California. This role involves providing regulatory advice, managing submissions to health authorities, and leading cross-functional teams. The ideal candidate should have a Bachelor’...
- ...clinical-stage biotechnology company in Redwood City, CA, seeks a Sr. Director of Analytical Development and Quality Control. This role... ...providing technical leadership for methods development and oversight of CMC activities. Candidates must have over 15 years of experience in...Senior
$170k - $200k
...A leading biotechnology company in Redwood City is seeking an Associate Director of Program Management to oversee RNA manufacturing initiatives. This role involves leading complex projects, collaborating with internal and external teams, and ensuring successful program...Senior$124.6k - $213.8k
...Joby is looking for a Supply Chain Program Manager Lead in San Carlos, California. In this role, you will manage and develop a team ensuring on-time supply chain readiness, while collaborating with engineering and manufacturing teams. The ideal candidate has over 8 years...Senior$244k - $305k
...Senior Director, Head Of Early Development Regulatory Affairs Redwood City, California, United States Revolution Medicines... ...Regulatory Affairs will lead global regulatory strategy for early... ...excellence in early regulatory planning, submission readiness, and execution....SeniorFull timeLocal area$180k - $210k
...A leading robotics company in California is hiring a Senior Robotics Engineering Manager for Autonomy to lead a team focused on real-time robot navigation and motion planning. This role involves strong technical expertise and people leadership. Responsibilities include...Senior
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