Senior Regulatory Affairs Specialist: US Submissions
Aditi Consulting
Company in Thousand Oaks, CA is seeking a Regulatory Affairs professional to support US submissions, manage documentation, and coordinate with the Global Regulatory Team. The role focuses on IND submissions, agency meetings, and maintaining regulatory history across systems. The position emphasizes collaboration, communication, and compliance with regulatory standards, with salary paid as an hourly wage and comprehensive benefits. #J-18808-Ljbffr Aditi Consulting
$101.68k - $137.56k
...thrive as part of the Amgen team. Join us and transform the lives of patients... ...career. Sr. Associate, Nonclinical Regulatory Specialist What you will do Let’s do this. Let’... ...intersection of science, regulatory affairs, and submission management. As a member of the...SeniorFlexible hours$29 - $31 per hour
...obesity-related conditions. Join us and transform the lives of... ...Responsibilities Assist the US Regulatory Leads and the Global Regulatory... ...Team (GRT) in the Regulatory Affairs organization. Coordinate and execute US regulatory submissions under the direction of the US...SeniorHourly payFull timeLocal areaFlexible hours- Merck & Co. is seeking a Senior Associate - Regulatory Affairs, Oncology to support US regulatory activities for oncology programs. The role is remote in the US... ...the US Regulatory Lead and GRT to ensure timely submissions and compliant documentation. You will manage preparation...SeniorRemote job
- ...with flexible remote options or within commutable distance to ATO for onsite audits. Primary duties include HTS/ECCN classification, documentation review, EEI submission via AES, sanctions screening using SAP-GTS, and HTS US classification. #J-18808-Ljbffr Merck & Co.SeniorRemote jobFlexible hours
$32 - $33.55 per hour
...Description: In this vital role you will assist the US Regulatory Leads and the Global Regulatory Team (GRT) in the Regulatory Affairs organization. To coordinate and execute US regulatory submissions under the direction of the US Regulatory Lead in compliance...SeniorHourly payContract workLocal area- ...Sr. Regulatory Affairs Specialist 100% ONSITE in Westlake Village, California Sponsorship is not available for this role Caldera... ...regulatory bodies. From developing and authoring regulatory submissions to providing critical input on cross-functional project teams...SeniorWork at officeLocal areaWorldwide
- Amgen Inc. (IR) is seeking a Sr. Associate, Nonclinical Regulatory Specialist to coordinate regulatory readiness for nonclinical deliverables... ...operates at the intersection of science, regulatory affairs, and submission management, partnering with global teams to ensure...Senior
- Amgen is seeking a Senior Manager of US Forecasting in Oncology to partner with Commercial leadership, develop data-driven forecasts, and guide strategic brand decisions. The role involves influencing a broad set of stakeholders across Commercial, R&D, Medical, and Finance...Senior2 days per week3 days per week
$85.8k - $104.8k
...United States of AmericaQuality and Regulatory AffairsJob descriptionJOB SUMMARY:The Regulatory Affairs Specialist is responsible for planning,... ...and managing global regulatory submissions and registrations for medical devices, including US 510(k), EU technical...Contract workWorldwide- Envista is seeking a Regulatory Affairs Specialist to plan, prepare, and coordinate global regulatory submissions for medical devices, including US 510(k) and EU documentation. You will work with cross-functional teams to assess regulatory impact of design changes and...
$155.75k - $210.72k
...challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.Senior Manager, US Primary Market ResearchWhat you will doLet’s do this. Let’s change the world. In...SeniorFull timeWork at officeFlexible hours2 days per week3 days per week- Amgen is seeking a Process Development Senior Principal Scientist to lead analytical efforts for late-stage oligonucleotide programs... ...collaborate with manufacturing, quality, and regulators, and contribute to regulatory submissions and PPQ activities. #J-18808-Ljbffr BioSpaceSenior
- Implant Direct in Thousand Oaks, CA is seeking a Regulatory Affairs Specialist to manage global regulatory submissions for medical devices, including US 510(k), EU technical documentation, and international dossiers. The role represents Regulatory Affairs on cross-functional...
- ...Inc. is seeking a Safety Pharmacology Senior Scientist to develop integrated safety... ...collaborate across project teams to support regulatory submissions and decision-making processes. This... ...and effective communication skills. Join us in making a positive impact on patient...Senior
- Summary: Technical Documentation), CE Marking dossiers, 510(k) (if applicable), and country-specific submissions. ~ Experience working with Notified Bodies and global regulatory agencies for product approvals and compliance matters Our Culture- Where Career and...SeniorFull timeLocal areaWorldwide
$60 per hour
Manager of Supply Chain Compliance - Ensign‑Bickford Aerospace & Defense Company Lead procurement and trade compliance across aerospace & defense operations. Responsibilities: Execute GDP/GMP and business processes within GD America’s Hub with minimal supervision. Manage...SeniorHourly payPermanent employmentFull timeContract workTemporary work- A leading recruitment agency seeks a Sr. Accounting Analyst in Westlake Village, CA. The role involves ensuring accuracy in financial reporting, managing monthly closes, and supporting budgeting processes. Candidates should have a Bachelor's degree and 5-7 years of relevant...SeniorFull time
- ...patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives. BAI Senior Manager, US Forecasting, Oncology What you will do The Forecasting team at Amgen plays a pivotal role as a strategic partner to...SeniorWork at officeFlexible hoursShift work2 days per week3 days per week
- A leading asset-recovery firm in Thousand Oaks, California, is seeking a professional to train attorneys and manage legal documentation. The role involves ensuring compliance with company policies, auditing files, and updating case information. Ideal candidates will work...Senior
$157.74k - $213.41k
...lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your... ...documents, technical protocols, reports, product impact assessments, regulatory submissions, and developing responses to regulatory questions.Deliver...SeniorFull timeTemporary workFlexible hours$126.07k - $170.56k
...thrive as part of the Amgen team. Join us and transform the lives of patients while... ...your career.Process Development Senior ScientistWhat you will doLet’s do this.... ...manufacturing, technology transfer, and regulatory submissions. The scientist may support multiple fast...SeniorFull timeFlexible hours$129.23k - $174.84k
...thrive as part of the Amgen team. Join us and transform the lives of patients while... ...your career.Safety Pharmacology Senior ScientistWhat you will doLet’s do this.... ...candidate selection, IND-enabling packages and regulatory submissions. This role will require strong...SeniorFull timeContract workFlexible hours$168.39k - $227.83k
...you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.Senior Principal ScientistWhat you will doLet’s do... ...regulations.Support scientific work including regulatory compliance, trade associations, and professional...SeniorFull timeWork at officeRemote workFlexible hours$126.07k - $170.56k
...lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your... ...biologic drug products; and authoring and supporting high quality regulatory submissions. Work effectively in a fast-paced, matrixed environment,...SeniorFull timeFlexible hours$55.35 - $87.39 per hour
...the supervision of the Supervisor or Management, the Technical Specialist plans, directs and coordinates all technical activities performed... ...prohibited by local, state, or federal law. We believe diversity makes us stronger, so we are dedicated to shaping an inclusive workforce,...SeniorMinimum wageFull timeLocal areaShift work$148.72k - $201.2k
...part of the Amgen team. Join us and transform the lives of patients... ...transforming your career.Senior Manager, Instructional Design... ...product development and submission activities.The successful candidate... ...closely with Human Factors, Regulatory Labeling, Packaging...SeniorFull timeFor contractorsFlexible hours$20 per hour
...wage starting at $20 per hour. Position is available mid August. If you are interested in this rewarding opportunity, please message us to discuss further details. We look forward to hearing from you and potentially welcoming you to our family. Please visit to view...SeniorHourly payFull timePart timeLive outLive in- The Senior Manager, Drug Substance Development is a key member of... ...Collaborate closely with Quality, Regulatory, Analytical, Drug Product,... ...reports, regulatory submissions, and responses to health authority... ...5% of time worked. Why Join Us? Arcutis is a pioneering medical...SeniorFor contractorsLocal area
$111.94k - $151.45k
...part of the Amgen team. Join us and transform the lives of patients... ...your career.Scientist/ Senior Engineer - Drug Product Process... ..., manufacturing, quality, regulatory, and analytical information to... ...impact assessments, regulatory submission sections, responses to...SeniorFull timeContract workFlexible hours$126.07k - $170.56k
...part of the Amgen team. Join us and transform the lives of patients... ...transforming your career.Senior ScientistWhat you will doLet’s... ...product impact assessments, and regulatory sections in support of IND and marketing application submissions.Deliver progress reports and...SeniorFull timeWorldwideFlexible hours
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