Senior Regulatory Submissions Specialist
Corcept Therapeutics
Corcept Therapeutics is seeking a Senior Associate, Regulatory Operations to support regulatory submissions and maintain Veeva Vault records. You will collaborate with cross‑functional teams and vendors to ensure timely, compliant filings. A BA/BS in a scientific discipline and 3+ years of pharma regulatory experience are preferred. This headquarters‑based role requires meticulous attention to detail, strong communication skills, and the ability to manage multiple projects in a fast‑paced #J-18808-Ljbffr Corcept Therapeutics
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Senior Regulatory Submissions Specialist in Redwood City, CA vacancy
$125.6k - $177.3k
...in Redwood City, California. To learn more, visit The Senior Associate, Regulatory Operations will report to the Director of Regulatory Operations... ..., and vendors to manage regulatory requirements and submissions. Responsibilities Compile, format, and publish electronic...SeniorFull time- ...in Redwood City, California, is seeking an Associate to support Regulatory leadership in global nonclinical and clinical regulatory strategies, preparing for health authority interactions and submissions. This hybrid role typically requires on-site presence three days...Suggested3 days per week
$125.6k - $177.3k
...Corcept Therapeutics seeks a Senior Associate in Regulatory Operations to support regulatory submissions and compliance activities. The role involves managing electronic submissions to health authorities, maintaining regulatory systems, and collaborating across departments...Senior- ...companies in the field. PURPOSE OF JOB : The Senior Regulatory Affairs Specialist is responsible for executing international regulatory activities... ...products, with primary responsibility for regulatory submissions, registrations, and lifecycle activities in the United...SeniorTemporary workWork experience placementSummer work
$148.2k - $293.9k
Staff/Senior Staff/Principal Electrical Systems Engineer At PacBio we create the world... ...designs comply with applicable regulatory, safety, EMC, and environmental requirements... ..., applications or resumes, and any such submissions will be considered unsolicited. PacBio does...SeniorWork from homeMonday to Friday$226.19k - $292.71k
...to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.As the Senior Director - U.S. Ethics & Compliance Advisor (HIV), you will act as the key point of ethics and compliance support for relevant Gilead...SeniorFull timeFor contractorsLocal areaGILEAD Sciences
San Mateo, CA6 days ago- Senior Compliance Officer, Global R&D and Tech Ops Join to apply for the Senior Compliance Officer, Global R&D and Tech Ops role at BioSpace Reporting to the Chief Ethics and Compliance Officer, the Senior Compliance Officer is a senior member of the Ethics, Compliance...Senior
- Ashurst Perkins Coie US LLP is seeking a qualified Conflicts Attorney to analyze conflicts of interest for new business and lateral hires, provide guidance to firm lawyers, and ensure compliance with ethical standards across jurisdictions. The role requires JD and at least...Senior
$143k - $218k
...determined by the business needs of the team. LinkedIn is seeking a Senior Technical Risk & Compliance Engineer to support the end-to-end... ...with Security and Engineering teams to translate security, regulatory, policy, and assurance requirements into actionable control requirements...SeniorFor contractorsWork at officeFlexible hoursLinkedin
Mountain View, CA2 days ago- Job Description Job Description Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience...Senior
Mentor Technical Group
Redwood City, CA29 days ago - ...leading clinical-stage biotech company is seeking a Director/Senior Director for the Lirentelimab CMC team in Redwood City, CA.... ...Biologics CMC expertise, leadership capabilities, and experience in regulatory submissions. The position offers a competitive salary commensurate with...Senior
- ...Revolution Medicines seeks a Senior Medical Director to lead clinical development of oncology... ...focuses on ensuring data integrity, regulatory compliance, and successful preparation... ...clinical datasets for global regulatory submissions. Responsibilities Oversee data integrity...Senior
Revolution Medicines
Redwood City, CA18 days ago $90k - $135k
...Senior Regulatory Affairs Specialist supporting post-market compliance for in vitro diagnostic products in US and international markets. Responsibilities... ..., and strategies for domestic and international submissions Represent regulatory affairs function on cross-functional...SeniorWork at officeRemote work- Corcept Therapeutics, headquartered in Redwood City, CA, seeks an experienced Regulatory Medical Writer to author and edit NDAs, protocols, and CSRs for global regulatory submissions. You will collaborate with cross-functional teams to gather inputs and manage timelines...Senior
- ...while supervising a small team of programmers or CRO partners. The role involves CDISC SDTM/ADaM data generation, TLFs, and regulatory submission support. The candidate will ensure QA, write validation and batch scripts, and contribute to programming standards, templates...Senior
- ...Revolution Medicines seeks a Senior Scientist II in Process Chemistry to lead hands-on... ...chemistry with cross-functional leadership, regulatory support, and manufacturing scale-up... ...problems Direct contribution to regulatory submissions and process scale-up activities...Senior
Revolution Medicines
Redwood City, CA2 days ago - ...Senior Workday Functional Architect (Contract & FTE)-5 Need 14+ years profile with strong... ...time-tracking configuration, time submissions, and employee work schedules. Experience... ...(Journal Lines) Knowledge of payroll regulatory rules and their impact on payroll configuration...SeniorFull timeContract work
Realign Llc
Menlo Park, CA4 days ago - ...Medicine at Stanford Medicine is seeking a Clinical Trials Regulatory Specialist 1 to provide centralized regulatory support for a diverse portfolio... ...the Role EntailsSupporting Study Start-Up and Regulatory Submissions. This position supports new clinical research studies from...Local areaWorldwide
Stanford University
Palo Alto, CA7 days ago - ...Corcept Therapeutics seeks a Senior Medical Director for Oncology to design and oversee... ...protocols, investigator brochures, and regulatory documents for clinical trials Provide... ...on clinical data analysis and regulatory submissions including IND and NDA filings Requirements...Senior
Corcept Therapeutics
Redwood City, CA18 days ago $55 - $60 per hour
...Job Description Job Description Job Title: Sr. Regulatory Affairs Specialist Location: Sunnyvale, CA, United States Type: Contract... ...design/process changes. Prepare and maintain regulatory submissions, including U.S. FDA 510(k) premarket notifications, Letters...SeniorContract workLocal area$165.15k - $242.82k
...California. To learn more, visit The Senior Manager, Biostatisticswill be... ...Partner with Clinical Development, Regulatory, Manufacturing, and Commercial organizations... ...completeness, regulatory standards compliance, and submission readiness Stay current with regulatory...SeniorFull timeFor contractors3 days per weekCorcept Therapeutics
Redwood City, CA1 day ago- ...Revolution Medicines seeks a Senior Safety Scientist II to provide pharmacovigilance and... ...clinical trial protocol assessment, and regulatory document preparation.... ...external stakeholders Support regulatory submissions including NDAs, BLAs, and responses to agency...Senior
Revolution Medicines
Redwood City, CA18 days ago - Our client, a top-tier law firm in California, is seeking a Senior Business Development Manager to support partners with compelling... ...showcase the firm's experience and capabilities. You will coordinate submissions to league tables and surveys, work with Digital and...Senior
- Senior Quality EngineerLocation: Menlo Park, CA (Onsite)A fast-... ..., Operations, Clinical, and Regulatory Affairs teams, leading quality... ...other premarket regulatory submissions.Supplier audit experience... ...in the future.EOE Statement: Specialist Staffing Group is an equal opportunity...SeniorContract workRelocationVisa sponsorshipRelocation package
Real Staffing Group
Menlo Park, CA3 days ago $165k - $192k
...our portfolio through the development and regulatory stage gates required for commercial... ...in clinical studies and global marketing submissions. They will work closely with the Regulatory... ...Team and across teams.Reports to: Senior Director, Device Development and Commercialization...SeniorVaxcyte
San Carlos, CA3 days ago- ...comSenior EDC ProgrammerThe Opportunity:The Senior EDC Global Library Programmer serves as... ..., Clinical Operations, Quality, Regulatory, Information Technology, and external partners... ...data collection through analysis and submission.Program, troubleshoot, and maintain Rave...Senior
Planet Pharma
Redwood City, CA2 days ago - ...Position: Senior/Executive Medical Director, Medical Affairs and Clinical Development... ...monitoring plans, safety data reviews, and regulatory licensing applications Ensure safety... ...and preparation of regulatory submissions, documents including license applications...SeniorShift work
Allakos
Redwood City, CA2 days ago $140k - $160k
...world.Job DescriptionTurner & Townsend is seeking an experienced Senior Cost Manager and/or Quantity Surveyor to support a portfolio... ...updates.Prepare written comments to contractor and consultant submissions, including executive summaries.Coordinate all sources of cost...SeniorContract workFor contractorsFor subcontractorFlexible hoursTurner & Townsend
Menlo Park, CA4 days ago$180.57k - $224.31k
Every day, tens of millions of people come to Roblox to explore, create, play, learn, and connect with friends in 3D immersive digital experiences- all created by our global community of developers and creators. At Roblox, we’re building the tools and platform that empower...SeniorFull timeWork experience placementH1bWork at officeLocal areaVisa sponsorshipMonday to FridayRoblox
San Mateo, CA3 days ago- ...exceed the listed range. CANDIDATE PROFILE Hands-on Senior Recruiter with strong full-cycle recruiting and direct-sourcing... ...now or in the future. No C2C arrangements or third-party submissions will be considered. ROLE OVERVIEW We are seeking an...SeniorContract workMenlo Park, CA2 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Regulatory Submissions Specialist. Be the first to apply!
Related searches
- compliance officer Redwood City, CA
- coding compliance specialist Redwood City, CA
- research compliance officer Redwood City, CA
- compliance analyst Redwood City, CA
- regulatory specialist Redwood City, CA
- healthcare compliance officer Redwood City, CA
- regulatory compliance specialist Redwood City, CA
- regulatory analyst Redwood City, CA
- regulatory affairs consultant Redwood City, CA
- compliance consultant Redwood City, CA