American Regent Visa Sponsorship Jobs USA
American Regent is a pharmaceutical and biotechnology company known for its injectable drug products and specialty therapeutics. The company sponsors a range of work visas, making it a viable target for international candidates in scientific, clinical, and regulatory roles seeking U.S. employment.
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Get Access To All JobsINTRODUCTION
American Regent, Inc. seeks a Manager of Clinical Quality Assurance (CQA) in Shirley, NY responsible for the following:
ROLE AND RESPONSIBILITIES
- Manage the CQA activities associated with the development of study-specific audit plans and oversight of clinical quality assurance processes that contribute to the quality oversight of functions including Pharmacovigilance, Clinical Operations, Quantitative Sciences, and Regulatory Affairs.
- Evaluate compliance with all applicable government regulations, federal guidelines, company Standard Operating Procedures, and industry standards.
- Support the Head of Clinical Quality Assurance to ensure implementation and continuous improvement of all CQA processes.
- Lead quality oversight of assigned animal and/or human clinical study programs including independent planning and execution of audits according to developed study-specific audit plans to assure adherence to company Standard Operating Procedures and other specified standards, and any applicable regulatory requirements.
- Lead quality oversight of post-marketing Pharmacovigilance activities for human and animal products.
- Develop, plan, schedule, and conduct audits of clinical investigator sites, trial master files, systems/process, clinical study documents, clinical research and Pharmacovigilance vendors.
- Generate and issue audit reports to summarize results of conducted audits in accordance with company Standard Operating Procedures.
- Provide audit-related feedback to stakeholders.
- Review audit responses/CAPA(s) for acceptability and escalate issues in accordance with applicable company Standard Operating Procedures.
- Review, approve, and track CAPA completion in accordance with company Standard Operating Procedures.
- Close audit reports and file reports and associated documentation in accordance with company Standard Operating Procedures.
- Review and approve deviations to internal processes reported by Pharmacovigilance, Clinical Operations, Quantitative Sciences, and Regulatory Affairs.
- Lead process improvement activities to support inspection preparation/readiness activities.
- Lead key activities during regulatory inspections and/or external audits as directed.
- Provide management with support for continuous improvement activities.
- Lead the development and maintenance departmental Standard Operating Procedures and other Standards.
- Provide onboarding support to new CQA team members and mentoring as needed.
- Provide training to staff and on applicable regulations and guidelines including Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Pharmacovigilance (GVP).
- Provide independent regulatory requirement/compliance advice to Pharmacovigilance, Clinical Operations, Quantitative Sciences, and Regulatory Affairs functions.
BASIC QUALIFICATIONS
Bachelor’s degree in Regulatory Affairs, Health Administration, Pharmaceutical Science or a related field or foreign equivalent, plus five (5) years of experience working in a pharmaceutical, biotechnology, or healthcare environment. In addition, five (5) years of experience with the following is required:
- Experience in the management of CQA activities including system/process-related auditing;
- Investigator site, CRO, IRB, and Pharmacovigilance auditing experience;
- Medicinal product development and global clinical regulatory environment in pharmaceuticals or biotechnology environment including 21 CFR Part 11, 21 CFR 312, 21 CFR 314, EU Directives, Health Canada Regulations, and ICH E6 (R2); and
- Utilizing Quality Management Systems.
COMPENSATION
- Salary: $217,422.00 per year
LOCATION
Position is 100% remote.
Please apply at https://www.americanregent.com/Careers using Req. ID 103297.
American Regent celebrates diversity, and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
American Regent Inc. endeavors to make https://americanregent.com/Careers accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact John Rossini, Talent Acquisition Director at jrossini@americanregent.com.
American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.
Applicants have rights under Federal Employment Laws.
- FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
- Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
- Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf
Alert: We’re aware of individuals impersonating our staff to target job seekers. Please note:
- All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address.
- Our recruiting process includes multiple in person and/or video interviews and assessments.
- If you are unsure about the legitimacy of a message, contact John Rossini at jrossini@americanregent.com before responding.
- We never request payment, bank information, or personal financial details during our offer process.
Your security is important to us, and we encourage you to stay vigilant when job searching.
American Regent Inc. endeavors to make https://careers.americanregent.com/ accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.
INTRODUCTION
American Regent, Inc. seeks a Manager of Clinical Quality Assurance (CQA) in Shirley, NY responsible for the following:
ROLE AND RESPONSIBILITIES
- Manage the CQA activities associated with the development of study-specific audit plans and oversight of clinical quality assurance processes that contribute to the quality oversight of functions including Pharmacovigilance, Clinical Operations, Quantitative Sciences, and Regulatory Affairs.
- Evaluate compliance with all applicable government regulations, federal guidelines, company Standard Operating Procedures, and industry standards.
- Support the Head of Clinical Quality Assurance to ensure implementation and continuous improvement of all CQA processes.
- Lead quality oversight of assigned animal and/or human clinical study programs including independent planning and execution of audits according to developed study-specific audit plans to assure adherence to company Standard Operating Procedures and other specified standards, and any applicable regulatory requirements.
- Lead quality oversight of post-marketing Pharmacovigilance activities for human and animal products.
- Develop, plan, schedule, and conduct audits of clinical investigator sites, trial master files, systems/process, clinical study documents, clinical research and Pharmacovigilance vendors.
- Generate and issue audit reports to summarize results of conducted audits in accordance with company Standard Operating Procedures.
- Provide audit-related feedback to stakeholders.
- Review audit responses/CAPA(s) for acceptability and escalate issues in accordance with applicable company Standard Operating Procedures.
- Review, approve, and track CAPA completion in accordance with company Standard Operating Procedures.
- Close audit reports and file reports and associated documentation in accordance with company Standard Operating Procedures.
- Review and approve deviations to internal processes reported by Pharmacovigilance, Clinical Operations, Quantitative Sciences, and Regulatory Affairs.
- Lead process improvement activities to support inspection preparation/readiness activities.
- Lead key activities during regulatory inspections and/or external audits as directed.
- Provide management with support for continuous improvement activities.
- Lead the development and maintenance departmental Standard Operating Procedures and other Standards.
- Provide onboarding support to new CQA team members and mentoring as needed.
- Provide training to staff and on applicable regulations and guidelines including Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Pharmacovigilance (GVP).
- Provide independent regulatory requirement/compliance advice to Pharmacovigilance, Clinical Operations, Quantitative Sciences, and Regulatory Affairs functions.
BASIC QUALIFICATIONS
Bachelor’s degree in Regulatory Affairs, Health Administration, Pharmaceutical Science or a related field or foreign equivalent, plus five (5) years of experience working in a pharmaceutical, biotechnology, or healthcare environment. In addition, five (5) years of experience with the following is required:
- Experience in the management of CQA activities including system/process-related auditing;
- Investigator site, CRO, IRB, and Pharmacovigilance auditing experience;
- Medicinal product development and global clinical regulatory environment in pharmaceuticals or biotechnology environment including 21 CFR Part 11, 21 CFR 312, 21 CFR 314, EU Directives, Health Canada Regulations, and ICH E6 (R2); and
- Utilizing Quality Management Systems.
COMPENSATION
- Salary: $217,422.00 per year
LOCATION
Position is 100% remote.
Please apply at https://www.americanregent.com/Careers using Req. ID 103297.
American Regent celebrates diversity, and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
American Regent Inc. endeavors to make https://americanregent.com/Careers accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact John Rossini, Talent Acquisition Director at jrossini@americanregent.com.
American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.
Applicants have rights under Federal Employment Laws.
- FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
- Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
- Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf
Alert: We’re aware of individuals impersonating our staff to target job seekers. Please note:
- All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address.
- Our recruiting process includes multiple in person and/or video interviews and assessments.
- If you are unsure about the legitimacy of a message, contact John Rossini at jrossini@americanregent.com before responding.
- We never request payment, bank information, or personal financial details during our offer process.
Your security is important to us, and we encourage you to stay vigilant when job searching.
American Regent Inc. endeavors to make https://careers.americanregent.com/ accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.
Job Roles at American Regent
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Get Access To All JobsTips for Finding American Regent Visa Sponsorship Jobs USA
Target roles in scientific and regulatory functions
American Regent's sponsorship activity is concentrated in technical and scientific disciplines. Focus your search on roles in pharmaceutical development, quality assurance, regulatory affairs, and clinical operations, where visa sponsorship is most commonly tied to specialized degree requirements.
Understand which visa types American Regent supports
American Regent sponsors H-1B, Green Card, F-1 OPT, F-1 CPT, and TN visas. Knowing which category fits your status helps you tailor your application and have an informed conversation with their HR or talent acquisition team early.
Leverage F-1 OPT and CPT as an entry point
If you're a current F-1 student in a life sciences or pharmaceutical field, American Regent's support for OPT and CPT makes it a strong target for internships and early-career roles that can develop into long-term sponsored employment.
Research their injectable therapeutics pipeline before applying
American Regent specializes in iron deficiency and injectable therapies. Candidates who demonstrate familiarity with their product lines and manufacturing approach stand out, particularly in formulation, analytical chemistry, and drug safety roles.
Use Migrate Mate to confirm sponsorship history before applying
Before investing time in an application, verify that American Regent has an active sponsorship track record in your visa category. Migrate Mate surfaces verified sponsors so you can filter by real sponsorship history and avoid wasted effort.
Engage early about sponsorship during the interview process
Pharmaceutical companies like American Regent typically route sponsorship decisions through HR and legal teams. Raising your visa situation respectfully but early, before final rounds, avoids surprises and gives both sides time to align on timeline and paperwork.
Frequently Asked Questions
Does American Regent sponsor H-1B visas?
Yes, American Regent sponsors H-1B visas. The company operates in the biotechnology and pharmaceuticals industry, where H-1B sponsorship is common for specialized roles requiring a relevant bachelor's degree or higher. Candidates in scientific, regulatory, and technical functions are the most likely to be considered for H-1B sponsorship at American Regent.
Which visa types does American Regent sponsor?
American Regent sponsors H-1B and Green Card visas for longer-term employment, and also supports F-1 OPT and F-1 CPT for students and recent graduates. TN visas are also on the supported list, making American Regent a viable option for Canadian and Mexican nationals in qualifying pharmaceutical and scientific roles.
Which departments or roles at American Regent are most likely to offer visa sponsorship?
Sponsorship at American Regent tends to align with roles that require specialized technical expertise, particularly in pharmaceutical sciences, regulatory affairs, quality control, analytical chemistry, and drug manufacturing. These functions rely on degree-specific knowledge that supports H-1B specialty occupation eligibility, making them the strongest targets for international candidates.
How do I find open visa-sponsored jobs at American Regent?
The most reliable approach is to use Migrate Mate, which tracks verified sponsorship histories and lets you filter opportunities by visa type and company. This helps you confirm that American Regent is actively sponsoring in your category before applying, saving time and giving you a clearer picture of your chances.
How do I approach the application process at American Regent as an international candidate?
Start by identifying roles that align with your degree and field, since American Regent's sponsorship is concentrated in technical disciplines. Be transparent about your visa status early in the process. Their HR team handles sponsorship through established legal channels, so raising the topic professionally during initial conversations is expected and helps set realistic timelines for both sides.