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 Corcept Therapeutics
- 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
- 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
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...SuggestedFull time3 days per week- Position: Executive Director, Regulatory Affairs CMC Location: Redwood City, CA Job Id: 270-1156 # of... ...marketing of drug products. They will: Lead teams with regulatory CMC... ...implements CMC regulatory strategies for CTA submissions and marketing applications. This...Suggested
$157.59k - $203.94k
...Senior Manager, CMC Regulatory Affairs for Biologics At Gilead, we're creating a healthier world for all... ...approvals of CMC regulatory (Biologics) submissions, and "right to operate" by... ...JOB DESCRIPTION CMC regulatory lead for a single or multiple products....SeniorWork experience placement$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- 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
- ...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...
$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$250k - $275k
...diseases. Founded in 2020 by a leading team of R&D experts and... ...motivated and experienced Senior Director of Regulatory Affairs to lead global regulatory... ...strategies, overseeing submission activities (INDs, CTAs, NDAs... ...alignment with clinical, CMC, nonclinical, and corporate...SeniorWork at officeRemote work2 days per week3 days per week- ...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
...patients for generations to come. As a Director, Global Regulatory Affairs CMC, at Gilead you will...be... ...viral vector-based products. This role leads the development, compilation, review... ...Module, Module 3) for global regulatory submissions, including clinical trial...Full timeFor contractorsWork at officeLocal areaRemote workRelocationFlexible hoursShift work$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$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- ...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...
- ...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
- 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’s...
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$96k - $144k
Equinix is seeking a skilled Sr. Specialist, Event Logistics to join their Global Events team in Redwood City, CA. This role is pivotal in managing logistics, budgeting, and vendor coordination for various events. The ideal candidate is a strategic thinker with 4+ years...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$195k - $215k
...external partners. Ideal candidates will have 7+ years of small molecule analytical development experience and a deep understanding of regulatory frameworks. Compensation ranges from $195,000 to $215,000 annually, along with comprehensive benefits including medical insurance...Senior$150k - $220k
Excellence Services, LLC is seeking a Head of Talent & Recruiting for a private household with a focus on high-trust environments. This full-time role, offering between $150K and $220K, requires a strong HR leader with experience in recruiting and the ability to drive hiring...SeniorFull timeRemote work$155k - $190k
...Senior Preconstruction & Estimating Lead Pleasanton, CA Reports To: Chief Estimator Compensation: $155,000 - $190,000/year + benefits ABOUT THE COMPANY: ~ A well-established general contractor specializing in commercial, residential, healthcare...SeniorContract workFor contractorsFor subcontractorWork at officeLocal area$276k - $318k
...biotechnology company in Palo Alto is seeking a Biostatistician to lead biostatistical analyses and ensure clinical project... ...with cross-functional teams to support clinical trials and regulatory submissions. Candidates must have a PhD in a related field and at least...Senior- ...General Description: The Director, Global Regulatory Lead, will be responsible for... ...individual has regulatory affairs departmental and cross functional... ...the preparation and submission of global regulatory... ...with BeOne employees and senior management. Interacts with...Temporary workWork experience placementShift work
- Alation is seeking a Senior Revenue Operations Analyst to focus on Deal Desk and Commercial Operations. This hybrid role involves leading deal structuring, supporting sales processes, and optimizing revenue operations while ensuring compliance across teams. Ideal candidates...Senior
- A cutting-edge technology company in Redwood City is seeking a visionary Principal Engineer to bridge architecture and execution, focusing on AI enterprise integration. The ideal candidate will have over 10 years of engineering experience, with a strong background in machine...Senior
$121.3k - $181.9k
Together Labs in Redwood City, California, is seeking a Senior Manager of User Acquisition to drive mobile growth through data-informed strategies and hands-on execution. This role requires 6+ years of experience in mobile user acquisition and a strong background in managing...Senior- Poshmark is seeking a Sr. Lead Data Analyst for their Analytics team in Redwood City. In this role, you will partner with Product, Engineering, and Business leaders, overseeing analytics initiatives and designing A/B tests to enhance the live shopping experience. The ideal...Senior
$162k - $186k
...Senior Manager, Regulatory Affairs Guilford, Connecticut or Palo Alto, CA - Hybrid Hyperfine, Inc. is... ...Responsibilities: Develop and lead regulatory strategies for Class I devices... ...with business priorities. Define submission plans, timelines, and resourcing;...SeniorWork at officeWork visaShift workNight shiftWeekend work3 days per week
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