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3966 regulatory affairs manager ii jobs found

    • chicago, illinois (remote)
    • contract
    • $60 - $64.12 per hour
    job summary: Regulatory Affairs Manager II 12 Month Contract | REMOTE Join a leading biopharma company supporting critical regulatory systems initiatives. We're seeking a detail-oriented consultant with expertise in Regulatory Systems, eCTD submission management, and experience working with global IT and cross-functional teams to drive system implementation and Quality Control Process, Documentation & Testing. Key Focus Areas: Regulatory Systems Expertise
    job summary: Regulatory Affairs Manager II 12 Month Contract | REMOTE Join a leading biopharma company supporting critical regulatory systems initiatives. We're seeking a detail-oriented consultant with expertise in Regulatory Systems, eCTD submission management, and experience working with global IT and cross-functional teams to drive system implementation and Quality Control Process, Documentation & Testing. Key Focus Areas: Regulatory Systems Expertise
    • north chicago, illinois
    • contract
    • $35 - $41 per hour
    job summary: Immediate opportunity for a Sr. Regulatory Affairs Associate, CMC to assist the technical team in preparing regulatory filing dossiers, assess changes for regulatory impact, and manage documentation systems. You will participate in Global Regulatory Product Team (GRPT) and Operations Brand Team meetings as needed. As a Senior Associate, RA CMC, you will work with internal and external partners in order to deliver products to patients. Prepare
    job summary: Immediate opportunity for a Sr. Regulatory Affairs Associate, CMC to assist the technical team in preparing regulatory filing dossiers, assess changes for regulatory impact, and manage documentation systems. You will participate in Global Regulatory Product Team (GRPT) and Operations Brand Team meetings as needed. As a Senior Associate, RA CMC, you will work with internal and external partners in order to deliver products to patients. Prepare
    • fort worth, texas
    • contract
    • $50 - $65.22 per hour
    job summary: Join a leading team in Life Cycle Management (LCM) for Vision Care! Seeking a clinical expert with experience in EUMDR, medical / clinical writing, and ophthalmology / eye care to support regulatory documentation and post-production risk reviews. Location: Fort Worth, TX (Onsite preferred; candidates will be considered for remote work within CST or EST time zones). location: Fort Worth, Texas job type: Contract salary: $50.00 - 65.
    job summary: Join a leading team in Life Cycle Management (LCM) for Vision Care! Seeking a clinical expert with experience in EUMDR, medical / clinical writing, and ophthalmology / eye care to support regulatory documentation and post-production risk reviews. Location: Fort Worth, TX (Onsite preferred; candidates will be considered for remote work within CST or EST time zones). location: Fort Worth, Texas job type: Contract salary: $50.00 - 65.
    • cambridge, massachusetts (remote)
    • contract
    • $116.13 - $138.17 per hour
    job summary: As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Our partner recognizes the need for innovative care and utilizes Research & Development to further knowle
    job summary: As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Our partner recognizes the need for innovative care and utilizes Research & Development to further knowle
    • south san francisco, california (remote)
    • contract
    • $75 - $95 per hour
    job summary: Sr. Manager, Clinical Supplies (Oral Solid Dose) 6 Month Contract (may extend or convert) Remote (75%) + 1 week / month in South SF Looking for West Coast Based Candidates (travel reimbursed) Must Have: Experience with oral tablet dosage form Phase 1 & Small Biotech experience APAC logistics experience is a plus Strong MS Excel skills Seeking a talented, independent, and highly motivated Senior Manager, Clinical Supplies Planning
    job summary: Sr. Manager, Clinical Supplies (Oral Solid Dose) 6 Month Contract (may extend or convert) Remote (75%) + 1 week / month in South SF Looking for West Coast Based Candidates (travel reimbursed) Must Have: Experience with oral tablet dosage form Phase 1 & Small Biotech experience APAC logistics experience is a plus Strong MS Excel skills Seeking a talented, independent, and highly motivated Senior Manager, Clinical Supplies Planning
    • cambridge, massachusetts (remote)
    • contract
    • $50 per hour
    job summary: Title: Global Case Management Specialist Location: Remote Reports to: Sr. Manager, PV Operations Global Case Management The Global Case Management Specialist will be responsible for effective execution of the activities of triage, processing, and quality control of individual case safety reports (ICSR) from clinical trials to ensure timely and accurate assessment of adverse event reports. This role will focus on accurate case entry and w
    job summary: Title: Global Case Management Specialist Location: Remote Reports to: Sr. Manager, PV Operations Global Case Management The Global Case Management Specialist will be responsible for effective execution of the activities of triage, processing, and quality control of individual case safety reports (ICSR) from clinical trials to ensure timely and accurate assessment of adverse event reports. This role will focus on accurate case entry and w
    • skaneateles falls, new york
    • temp to perm
    • $55 - $60 per hour
    job summary: Are you passionate about ensuring compliance and facilitating the approval of innovative products? We are seeking a dedicated Regulatory Affairs Specialist to manage and coordinate our regulatory submission processes. This role offers the flexibility of being fully remote or hybrid, catering to your work-life balance needs. location: Skaneateles Falls, New York job type: Contract salary: $55 - 60 per hour work hours: 8am to 4pm
    job summary: Are you passionate about ensuring compliance and facilitating the approval of innovative products? We are seeking a dedicated Regulatory Affairs Specialist to manage and coordinate our regulatory submission processes. This role offers the flexibility of being fully remote or hybrid, catering to your work-life balance needs. location: Skaneateles Falls, New York job type: Contract salary: $55 - 60 per hour work hours: 8am to 4pm
    • south san francisco, california (remote)
    • contract
    • $65 - $79.61 per hour
    job summary: We are seeking a Regulatory Submission Manager to support global regulatory initiatives and ensure compliance with regulatory requirements for investigational and marketed products. Role involves working closely with cross-functional teams and regulatory leads to support submission activities, labeling development, and strategic regulatory guidance. The ideal candidate has a strong background in regulatory submissions and document review, as
    job summary: We are seeking a Regulatory Submission Manager to support global regulatory initiatives and ensure compliance with regulatory requirements for investigational and marketed products. Role involves working closely with cross-functional teams and regulatory leads to support submission activities, labeling development, and strategic regulatory guidance. The ideal candidate has a strong background in regulatory submissions and document review, as
    • lone tree, colorado
    • temporary
    • $71.50 - $74 per hour
    Are you a problem-solver who thrives at the intersection of business and technology? Randstad is supporting a leading wealth management firm who is looking to hire a Project Manager/Business Analyst to join their Corporate Vendor Management team. This individual will play a critical role in driving strategic initiatives, streamlining processes, and delivering impactful results. You’ll work alongside cross-functional teams to design smarter workflows
    Are you a problem-solver who thrives at the intersection of business and technology? Randstad is supporting a leading wealth management firm who is looking to hire a Project Manager/Business Analyst to join their Corporate Vendor Management team. This individual will play a critical role in driving strategic initiatives, streamlining processes, and delivering impactful results. You’ll work alongside cross-functional teams to design smarter workflows
    • ridgefield, new jersey
    • contract
    • $40 - $42.50 per hour
    job summary: As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Located in 100 countries, our longtime partner is known for being the world's largest producer of vaccines
    job summary: As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Located in 100 countries, our longtime partner is known for being the world's largest producer of vaccines
    • sacramento, california
    • permanent
    • $95,000 - $125,000 per year
    "Passionate about food safety and quality? Join our team and play a key role in ensuring our products meet the highest industry standards! If you have an eye for detail, a commitment to excellence, and a drive to make a real impact, this is the opportunity for you!" About the Role: We are seeking a detail-oriented Quality Assurance Technician to join our team. In this role, you will be responsible for ensuring that our food products meet the highest stand
    "Passionate about food safety and quality? Join our team and play a key role in ensuring our products meet the highest industry standards! If you have an eye for detail, a commitment to excellence, and a drive to make a real impact, this is the opportunity for you!" About the Role: We are seeking a detail-oriented Quality Assurance Technician to join our team. In this role, you will be responsible for ensuring that our food products meet the highest stand
    • cambridge, massachusetts
    • contract
    • $65 - $68.97 per hour
    job summary: As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Located in 100 countries, our longtime partner is known for being the world's largest producer of vaccines
    job summary: As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Located in 100 countries, our longtime partner is known for being the world's largest producer of vaccines
    • houston, texas
    • contract
    • $28.68 - $33.74 per hour
    job summary: Seeking an experienced QC Microbiology Environmental Monitoring (EM) Analysts II for a leading Contract Development and Manufacturing Organization (CDMO) specializing in cell and gene therapy, located in Houston, TX. This role supports the Quality Control, Environmental Monitoring team in maintaining the cleanrooms for commercial manufacturing and environmental monitoring performance qualifications. This role will also be central in all proce
    job summary: Seeking an experienced QC Microbiology Environmental Monitoring (EM) Analysts II for a leading Contract Development and Manufacturing Organization (CDMO) specializing in cell and gene therapy, located in Houston, TX. This role supports the Quality Control, Environmental Monitoring team in maintaining the cleanrooms for commercial manufacturing and environmental monitoring performance qualifications. This role will also be central in all proce
    • houston, texas
    • contract
    • $28.68 - $33.74 per hour
    job summary: Seeking an experienced QC Microbiology Environmental Monitoring (EM) Analysts II for a leading Contract Development and Manufacturing Organization (CDMO) specializing in cell and gene therapy, located in Houston, TX. This role supports the Quality Control, Environmental Monitoring team in maintaining the cleanrooms for commercial manufacturing and environmental monitoring performance qualifications. This role will also be central in all proce
    job summary: Seeking an experienced QC Microbiology Environmental Monitoring (EM) Analysts II for a leading Contract Development and Manufacturing Organization (CDMO) specializing in cell and gene therapy, located in Houston, TX. This role supports the Quality Control, Environmental Monitoring team in maintaining the cleanrooms for commercial manufacturing and environmental monitoring performance qualifications. This role will also be central in all proce
    • cambridge, massachusetts (remote)
    • contract
    • $70 - $80 per hour
    job summary: Global Labeling Manager - Regulatory Affairs REMOTE | EST Hours Join a mission-driven team committed to ensuring the safe and effective use of pharmaceutical products worldwide. We're seeking a Global Labeling Manager with a passion for regulatory excellence, precision, and cross-functional collaboration. About the Role: As a Global Labeling Manager, you will drive global labeling strategy and ensure high-quality, compliant labeling documents
    job summary: Global Labeling Manager - Regulatory Affairs REMOTE | EST Hours Join a mission-driven team committed to ensuring the safe and effective use of pharmaceutical products worldwide. We're seeking a Global Labeling Manager with a passion for regulatory excellence, precision, and cross-functional collaboration. About the Role: As a Global Labeling Manager, you will drive global labeling strategy and ensure high-quality, compliant labeling documents
    • stone mountain, georgia
    • temporary
    • $17 per hour
    Ready to put your skills as a reliable, detail-oriented professional to use and grow in your career? We're hiring quality assurance (QA) specialists and technicians right now. What's in it for you? A consistent schedule. Opportunities to grow. Best-in-class benefits, including coverage for medical, vision and dental that can be extended to your family. Oh, and great pay, which you'll take home weekly. Read on to learn more about these great opportunities,
    Ready to put your skills as a reliable, detail-oriented professional to use and grow in your career? We're hiring quality assurance (QA) specialists and technicians right now. What's in it for you? A consistent schedule. Opportunities to grow. Best-in-class benefits, including coverage for medical, vision and dental that can be extended to your family. Oh, and great pay, which you'll take home weekly. Read on to learn more about these great opportunities,
    • jeffersonville, indiana
    • temporary
    • $19 - $20 per hour
    Ready to proactively identify problems with products and goods? In manufacturing and industrial environments, that's what quality assurance (QA) specialists and technicians do best. If you have what it takes to report and verify defects, troubleshoot on the fly and always operate with a safety mindset, your next career opportunity is waiting. Read on to learn more about the requirements for the role and how to apply. If you're qualified, we'll be sure to g
    Ready to proactively identify problems with products and goods? In manufacturing and industrial environments, that's what quality assurance (QA) specialists and technicians do best. If you have what it takes to report and verify defects, troubleshoot on the fly and always operate with a safety mindset, your next career opportunity is waiting. Read on to learn more about the requirements for the role and how to apply. If you're qualified, we'll be sure to g
    • cary, north carolina
    • contract
    • $23.06 - $31.36 per hour
    job summary: A Supply Management Specialist is needed for an American corporation that manufactures agricultural, construction, and forestry machinery, diesel engines, drivetrains (axles, transmissions, gearboxes) used in heavy equipment, and lawn care equipment in the Cary, NC area. This job manages sourcing and order fulfillment to ensure timely, cost-effective material delivery and supplier performance. location: Cary, North Carolina job type: Cont
    job summary: A Supply Management Specialist is needed for an American corporation that manufactures agricultural, construction, and forestry machinery, diesel engines, drivetrains (axles, transmissions, gearboxes) used in heavy equipment, and lawn care equipment in the Cary, NC area. This job manages sourcing and order fulfillment to ensure timely, cost-effective material delivery and supplier performance. location: Cary, North Carolina job type: Cont
    • kansas city, missouri
    • temporary
    • $18 - $25 per hour
    Ready to proactively identify problems with products and goods? In manufacturing and industrial environments, that's what quality assurance (QA) specialists and technicians do best. If you have what it takes to report and verify defects, troubleshoot on the fly and always operate with a safety mindset, your next career opportunity is waiting. Read on to learn more about the requirements for the role and how to apply. If you're qualified, we'll be sure to g
    Ready to proactively identify problems with products and goods? In manufacturing and industrial environments, that's what quality assurance (QA) specialists and technicians do best. If you have what it takes to report and verify defects, troubleshoot on the fly and always operate with a safety mindset, your next career opportunity is waiting. Read on to learn more about the requirements for the role and how to apply. If you're qualified, we'll be sure to g
    • warren, michigan
    • temporary
    • $18 per hour
    Ready to thrive as a quality assurance (QA) specialist or technician in the manufacturing space? A few things come to mind: Flexibility. Reliability. Being safety-minded, detail-oriented and unafraid to solve problems. If that sounds like you, we want to meet you in fact, we're hiring seasoned QA pros right now. Read on to learn a little bit more about the opportunity and how to apply. We'll set up online interviews with qualified candidates shortly.job s
    Ready to thrive as a quality assurance (QA) specialist or technician in the manufacturing space? A few things come to mind: Flexibility. Reliability. Being safety-minded, detail-oriented and unafraid to solve problems. If that sounds like you, we want to meet you in fact, we're hiring seasoned QA pros right now. Read on to learn a little bit more about the opportunity and how to apply. We'll set up online interviews with qualified candidates shortly.job s
    • north chicago, illinois (remote)
    • contract
    • $38 - $40 per hour
    job summary: A research-driven biopharmaceutical powerhouse focused on developing treatments for complex, hard-to-cure diseases. This esteemed company has brought 32 groundbreaking products to market, making a significant global impact. If you're ready to make your mark in the field and contribute to the future of innovative therapies, this is the opportunity for you! location: Telecommute job type: Contract salary: $38 - 40 per hour work hour
    job summary: A research-driven biopharmaceutical powerhouse focused on developing treatments for complex, hard-to-cure diseases. This esteemed company has brought 32 groundbreaking products to market, making a significant global impact. If you're ready to make your mark in the field and contribute to the future of innovative therapies, this is the opportunity for you! location: Telecommute job type: Contract salary: $38 - 40 per hour work hour
    • philadelphia, pennsylvania (remote)
    • contract
    • $69.48 - $81.06 per hour
    job summary: As a trusted staffing and recruitment partner, we are committed to connecting you with the perfect opportunity at a global biopharmaceutical leader focused on improving patients' lives. Leveraging our extensive network, we provide access to top-tier roles that allow you to grow and make a meaningful impact in the healthcare industry. This company is dedicated to developing life-changing medicines in neuroscience, oncology, and rare diseases,
    job summary: As a trusted staffing and recruitment partner, we are committed to connecting you with the perfect opportunity at a global biopharmaceutical leader focused on improving patients' lives. Leveraging our extensive network, we provide access to top-tier roles that allow you to grow and make a meaningful impact in the healthcare industry. This company is dedicated to developing life-changing medicines in neuroscience, oncology, and rare diseases,
    • warren, michigan (remote)
    • contract
    • $50 - $55.75 per hour
    job summary: We have a 12 month contract opportunity for an IT Service Management Sr. Analyst. This role is fully remote but must work CST business hours (8AM-4PM CST). Candidates must have 3+ years of relevant experience with ServiceNow to be considered location: Warren, Michigan job type: Contract salary: $50.00 - 55.75 per hour work hours: 8am to 5pm education: Bachelors responsibilities: Responsibilities: Immediate Contributi
    job summary: We have a 12 month contract opportunity for an IT Service Management Sr. Analyst. This role is fully remote but must work CST business hours (8AM-4PM CST). Candidates must have 3+ years of relevant experience with ServiceNow to be considered location: Warren, Michigan job type: Contract salary: $50.00 - 55.75 per hour work hours: 8am to 5pm education: Bachelors responsibilities: Responsibilities: Immediate Contributi
    • chino, california
    • temporary
    • $23 per hour
    Ready to put your skills as a reliable, detail-oriented professional to use and grow in your career? We're hiring quality assurance (QA) specialists and technicians right now. What's in it for you? A consistent schedule. Opportunities to grow. Best-in-class benefits, including coverage for medical, vision and dental that can be extended to your family. Oh, and great pay, which you'll take home weekly. Read on to learn more about these great opportunities,
    Ready to put your skills as a reliable, detail-oriented professional to use and grow in your career? We're hiring quality assurance (QA) specialists and technicians right now. What's in it for you? A consistent schedule. Opportunities to grow. Best-in-class benefits, including coverage for medical, vision and dental that can be extended to your family. Oh, and great pay, which you'll take home weekly. Read on to learn more about these great opportunities,
    • irving, texas (remote)
    • temporary
    • $25 - $30 per hour
    The Vendor Management Specialist is responsible for leading SOW activities including but not limited to reviewing, redlining, validating, requesting legal review, if applicable, and initiating approval flows for SOW contracts. Also, ensuring compliance with company policies, procurement standards and legal/privacy requirements. Must have contract review for risk experience specifically in Indirect Services. This position is 100% remote. Critical Skill
    The Vendor Management Specialist is responsible for leading SOW activities including but not limited to reviewing, redlining, validating, requesting legal review, if applicable, and initiating approval flows for SOW contracts. Also, ensuring compliance with company policies, procurement standards and legal/privacy requirements. Must have contract review for risk experience specifically in Indirect Services. This position is 100% remote. Critical Skill
    • baltimore, maryland
    • temporary
    • $21.33 - $21.34 per hour
    Are you a detail-oriented problem solver with organizational skills and a passion for finance? We’re looking for a skilled professional to join our team! In this role, you will navigate web-based applications, interpret a wide range of reference materials, and utilize third-party information platforms like Xcitek, Bloomberg, and SWIFT. Your ability to quickly adapt, take initiative, and collaborate with a team will be essential in ensuring accurate a
    Are you a detail-oriented problem solver with organizational skills and a passion for finance? We’re looking for a skilled professional to join our team! In this role, you will navigate web-based applications, interpret a wide range of reference materials, and utilize third-party information platforms like Xcitek, Bloomberg, and SWIFT. Your ability to quickly adapt, take initiative, and collaborate with a team will be essential in ensuring accurate a
    • los angeles, california (remote)
    • contract
    • $150 - $165.90 per hour
    job summary: This is a high level contract role, requiring Direct Global Regulatory Labeling Operations Project Management experience in the Pharma/Biotech industry, as deep knowledge of pharmaceutical labeling regulations, compliance, and processes are critical for this role. The Labeling Project Manager is responsible for all activities associated with the development, creation and execution of labeling for assigned product lines for domestic and/or i
    job summary: This is a high level contract role, requiring Direct Global Regulatory Labeling Operations Project Management experience in the Pharma/Biotech industry, as deep knowledge of pharmaceutical labeling regulations, compliance, and processes are critical for this role. The Labeling Project Manager is responsible for all activities associated with the development, creation and execution of labeling for assigned product lines for domestic and/or i
    • north chicago, illinois
    • contract
    • $40 - $46.95 per hour
    job summary: As the world's largest staffing and recruitment agency, we are dedicated to helping you find the ideal role that offers growth and development opportunities within the life sciences sector. By working with a recruiter, you gain access to a vast network of leading employers and detailed insights into a wide range of positions. One of our premier partnerships is with a research-driven biopharmaceutical powerhouse focused on developing treatment
    job summary: As the world's largest staffing and recruitment agency, we are dedicated to helping you find the ideal role that offers growth and development opportunities within the life sciences sector. By working with a recruiter, you gain access to a vast network of leading employers and detailed insights into a wide range of positions. One of our premier partnerships is with a research-driven biopharmaceutical powerhouse focused on developing treatment
    • north chicago, illinois
    • contract
    • $65 - $72.68 per hour
    job summary: We are seeking a Manager-level contractor role to support Neuroscience portfolio assets. The contractor will have the opportunity to support launch and on-market assets in Migraine. The purpose of this role is to provide meaningful, hands-on research experience and professional development opportunities to candidates with proven performance and leadership potential. Ideal candidates will combine technical and business knowledge with analytica
    job summary: We are seeking a Manager-level contractor role to support Neuroscience portfolio assets. The contractor will have the opportunity to support launch and on-market assets in Migraine. The purpose of this role is to provide meaningful, hands-on research experience and professional development opportunities to candidates with proven performance and leadership potential. Ideal candidates will combine technical and business knowledge with analytica
    • richburg, south carolina
    • permanent
    • $41,600 - $62,400 per year
    A manufacturing facility in Richburg, SC is looking for a Yard Manager looking to interview candidates ASAP. This role is fast paced and demanding. This company is growing quickly and willing to train for upward progression. This is a Direct Hire opportunity. This will operate off a Monday-Friday schedule from 7:00 AM-3:30 (sometimes 5:00) PM. You will need experience operating Heavy Industrial Equipment and managing associates. Working outside is a requir
    A manufacturing facility in Richburg, SC is looking for a Yard Manager looking to interview candidates ASAP. This role is fast paced and demanding. This company is growing quickly and willing to train for upward progression. This is a Direct Hire opportunity. This will operate off a Monday-Friday schedule from 7:00 AM-3:30 (sometimes 5:00) PM. You will need experience operating Heavy Industrial Equipment and managing associates. Working outside is a requir
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