H-1B Visa Regulatory Affairs Jobs
Regulatory Affairs roles qualify as H-1B visa specialty occupations because they require at least a bachelor's degree in life sciences, pharmacy, or a related technical field. Employers in pharma, biotech, and medical devices file LCAs with the DOL before sponsoring, and many actively recruit internationally trained RA professionals.
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Get Access To All JobsINTRODUCTION
The Sr. Specialist, Regulatory Affairs – Power Platform Solutions Specialist is a hands-on application support and configuration role supporting our system, the business-built country regulatory requirements management platform within Global Regulatory Affairs and Clinical Safety. Our system uses Microsoft Power Platform, including Dataverse, Power Apps, Power Automate, and Power BI, with Microsoft Teams and SharePoint supporting communications and support activities.
As a member of the Platform Team, the incumbent communicates directly with users who submit tickets to understand their issues and requests, documents basic business requirements, and helps deliver approved application improvements. The role configures Power Apps and Power Automate, investigates routine issues, supports data checks and testing, and maintains support documentation. The specialist works under the technical guidance of the System Platform Architect and Design Authority and coordinates priorities, user follow-up, and validation with the System Operations Lead. Complex architecture, integrations, security design, and deployment decisions remain with the appropriate technical leads.
Responsibilities
User Engagement & Business Analysis
- Contact users who raise tickets to clarify the issue or request, understand their current process, and confirm the expected outcome and business impact.
- Gather relevant examples, screenshots, affected records, and steps to reproduce an issue; distinguish application defects, data concerns, access requests, and enhancement requests.
- Document clear requirements, simple process steps, and acceptance criteria; confirm understanding with the requestor and review proposed changes with the System Operations Lead and technical team.
- Keep requestors informed of progress, outstanding questions, and next steps, and coordinate follow-up with the appropriate support or technical owner.
- Support user acceptance testing and confirm with requestors that the delivered change addresses the agreed need before recommending ticket closure.
Application Build & Configuration
- Configure and update Power Apps forms, views, and user-interface components using approved requirements and established patterns.
- Maintain Dataverse tables, columns, views, and basic business rules under technical guidance; support access requests using approved procedures.
- Build and maintain routine Power Automate flows, approvals, and notifications using standard connectors and established designs.
- Translate agreed user requirements into straightforward application changes, seeking technical review when needed.
- Suggest practical improvements to usability and routine workflows, and continue developing Power Platform skills.
Application Maintenance & Release Support
- Assist technical leads with preparing approved application changes for Development, Test/UAT, and Production environments.
- Follow established release checklists and change-control procedures for fixes and enhancements.
- Perform assigned pre-release and post-release checks and report unexpected results to the technical lead.
- Maintain release notes, test results, and change records; support deployment activities under technical supervision.
Data Quality & Maintenance Support
- Support routine data imports, cleanup, and approved corrections using established tools, templates, and procedures.
- Compare source and system records and perform field-level checks to identify missing or inaccurate information.
- Document data issues and work with requestors, business data owners, and technical leads to confirm appropriate corrections.
- Use approved source files and escalate complex migration, bulk-update, or scripting needs to technical specialists.
Defect Resolution, Testing & Production Support
- Investigate and reproduce routine Power Apps, Power Automate, data, and access issues; escalate complex issues with clear supporting details.
- Test application changes in Development before handoff for broader testing, including expected outcomes and common error scenarios.
- Document the issue, change made, expected behavior, and test results in the relevant ticket or change record.
- Coordinate with the System Operations Lead and requestors during user validation and follow up on unresolved issues or regressions.
- Participate in release support and post-release monitoring, routing unresolved technical problems to the appropriate technical lead.
Documentation, Compliance & Quality
- Maintain user requirements, configuration notes, workflow descriptions, support procedures, and user guidance.
- Follow established Power Platform standards, security procedures, and change controls when configuring or supporting applications.
- Participate in peer review and maintain complete ticket, testing, and change documentation to support traceability and audit readiness.
Cross-Functional Delivery & Continuous Improvement
- Collaborate with Regulatory Affairs business users, the System Operations Lead, and technical partners in a global, matrixed environment.
- Provide clear status updates, identify dependencies or blockers, and contribute task estimates to support prioritization.
- Identify recurring user questions and ticket trends and suggest practical application, process, or training improvements.
- Share knowledge and document repeatable procedures to help other support-team members respond consistently.
Education
- Bachelor’s degree or equivalent in Information Systems, Computer Science, Business, Engineering, Regulatory Affairs, Life Sciences, or a related discipline.
- Relevant Microsoft Power Platform training or certification is preferred; an advanced degree is not required.
REQUIRED EXPERIENCE
- Minimum of three (3) years of relevant experience in business application support, configuration, development, or business analysis, including hands-on Power Platform work.
- Practical experience configuring Power Apps and building or maintaining Power Automate flows.
- Working knowledge of Dataverse tables, columns, forms, views, and basic business rules, with an understanding of access controls.
- Experience speaking with users to clarify support tickets or requests and documenting business needs, expected outcomes, and acceptance criteria.
- Ability to reproduce routine application issues, gather supporting information, and recognize when technical escalation is needed.
- Experience checking data accuracy and supporting routine data maintenance using established procedures.
- Experience testing application changes, recording results, and supporting user acceptance testing.
- Ability to maintain clear ticket records, configuration notes, and user or support documentation and follow established change controls.
- Ability to communicate effectively with business users and technical colleagues across regions and time zones.
- Strong organization, problem-solving, and follow-through skills, with the ability to balance assigned support tickets and enhancement tasks.
PREFERRED EXPERIENCE
- Experience supporting pharmaceutical, biotechnology, regulatory, safety, clinical, or other regulated business processes.
- Familiarity with Power BI reports, SharePoint lists, Microsoft Teams, and standard Microsoft 365 connectors.
- Experience using Jira or comparable ticket and backlog tracking tools.
- Basic familiarity with Power Platform solutions, Development/Test/Production environments, and controlled release procedures.
- Experience supporting UAT, preparing simple process documentation, or providing user guidance and training.
- Interest in expanding Power Platform skills and improving business processes through low-code solutions.
REQUIRED SKILLS
- Application Configuration
- Business Requirements Documentation (BRD)
- Data Quality Management
- End User Communication
- Microsoft Dataverse
- Microsoft Power Platform
- Technical Troubleshooting
- Ticket Management
- User Acceptance Testing (UAT)
PREFERRED SKILLS
- Change Controls
- Microsoft Power BI
- Microsoft SharePoint
- Microsoft Teams
- Process Mapping
LOCATION
The primary location for this posting is:
USA - Pennsylvania - North Wales (Upper Gwynedd)
COMPENSATION
- The salary range for the primary location of this role is:
$106,200.00 - $167,200.00
This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts.
JOB POSTING END DATE
11/18/2026
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
REQUISITION ID
R424766
INTRODUCTION
The Sr. Specialist, Regulatory Affairs – Power Platform Solutions Specialist is a hands-on application support and configuration role supporting our system, the business-built country regulatory requirements management platform within Global Regulatory Affairs and Clinical Safety. Our system uses Microsoft Power Platform, including Dataverse, Power Apps, Power Automate, and Power BI, with Microsoft Teams and SharePoint supporting communications and support activities.
As a member of the Platform Team, the incumbent communicates directly with users who submit tickets to understand their issues and requests, documents basic business requirements, and helps deliver approved application improvements. The role configures Power Apps and Power Automate, investigates routine issues, supports data checks and testing, and maintains support documentation. The specialist works under the technical guidance of the System Platform Architect and Design Authority and coordinates priorities, user follow-up, and validation with the System Operations Lead. Complex architecture, integrations, security design, and deployment decisions remain with the appropriate technical leads.
Responsibilities
User Engagement & Business Analysis
- Contact users who raise tickets to clarify the issue or request, understand their current process, and confirm the expected outcome and business impact.
- Gather relevant examples, screenshots, affected records, and steps to reproduce an issue; distinguish application defects, data concerns, access requests, and enhancement requests.
- Document clear requirements, simple process steps, and acceptance criteria; confirm understanding with the requestor and review proposed changes with the System Operations Lead and technical team.
- Keep requestors informed of progress, outstanding questions, and next steps, and coordinate follow-up with the appropriate support or technical owner.
- Support user acceptance testing and confirm with requestors that the delivered change addresses the agreed need before recommending ticket closure.
Application Build & Configuration
- Configure and update Power Apps forms, views, and user-interface components using approved requirements and established patterns.
- Maintain Dataverse tables, columns, views, and basic business rules under technical guidance; support access requests using approved procedures.
- Build and maintain routine Power Automate flows, approvals, and notifications using standard connectors and established designs.
- Translate agreed user requirements into straightforward application changes, seeking technical review when needed.
- Suggest practical improvements to usability and routine workflows, and continue developing Power Platform skills.
Application Maintenance & Release Support
- Assist technical leads with preparing approved application changes for Development, Test/UAT, and Production environments.
- Follow established release checklists and change-control procedures for fixes and enhancements.
- Perform assigned pre-release and post-release checks and report unexpected results to the technical lead.
- Maintain release notes, test results, and change records; support deployment activities under technical supervision.
Data Quality & Maintenance Support
- Support routine data imports, cleanup, and approved corrections using established tools, templates, and procedures.
- Compare source and system records and perform field-level checks to identify missing or inaccurate information.
- Document data issues and work with requestors, business data owners, and technical leads to confirm appropriate corrections.
- Use approved source files and escalate complex migration, bulk-update, or scripting needs to technical specialists.
Defect Resolution, Testing & Production Support
- Investigate and reproduce routine Power Apps, Power Automate, data, and access issues; escalate complex issues with clear supporting details.
- Test application changes in Development before handoff for broader testing, including expected outcomes and common error scenarios.
- Document the issue, change made, expected behavior, and test results in the relevant ticket or change record.
- Coordinate with the System Operations Lead and requestors during user validation and follow up on unresolved issues or regressions.
- Participate in release support and post-release monitoring, routing unresolved technical problems to the appropriate technical lead.
Documentation, Compliance & Quality
- Maintain user requirements, configuration notes, workflow descriptions, support procedures, and user guidance.
- Follow established Power Platform standards, security procedures, and change controls when configuring or supporting applications.
- Participate in peer review and maintain complete ticket, testing, and change documentation to support traceability and audit readiness.
Cross-Functional Delivery & Continuous Improvement
- Collaborate with Regulatory Affairs business users, the System Operations Lead, and technical partners in a global, matrixed environment.
- Provide clear status updates, identify dependencies or blockers, and contribute task estimates to support prioritization.
- Identify recurring user questions and ticket trends and suggest practical application, process, or training improvements.
- Share knowledge and document repeatable procedures to help other support-team members respond consistently.
Education
- Bachelor’s degree or equivalent in Information Systems, Computer Science, Business, Engineering, Regulatory Affairs, Life Sciences, or a related discipline.
- Relevant Microsoft Power Platform training or certification is preferred; an advanced degree is not required.
REQUIRED EXPERIENCE
- Minimum of three (3) years of relevant experience in business application support, configuration, development, or business analysis, including hands-on Power Platform work.
- Practical experience configuring Power Apps and building or maintaining Power Automate flows.
- Working knowledge of Dataverse tables, columns, forms, views, and basic business rules, with an understanding of access controls.
- Experience speaking with users to clarify support tickets or requests and documenting business needs, expected outcomes, and acceptance criteria.
- Ability to reproduce routine application issues, gather supporting information, and recognize when technical escalation is needed.
- Experience checking data accuracy and supporting routine data maintenance using established procedures.
- Experience testing application changes, recording results, and supporting user acceptance testing.
- Ability to maintain clear ticket records, configuration notes, and user or support documentation and follow established change controls.
- Ability to communicate effectively with business users and technical colleagues across regions and time zones.
- Strong organization, problem-solving, and follow-through skills, with the ability to balance assigned support tickets and enhancement tasks.
PREFERRED EXPERIENCE
- Experience supporting pharmaceutical, biotechnology, regulatory, safety, clinical, or other regulated business processes.
- Familiarity with Power BI reports, SharePoint lists, Microsoft Teams, and standard Microsoft 365 connectors.
- Experience using Jira or comparable ticket and backlog tracking tools.
- Basic familiarity with Power Platform solutions, Development/Test/Production environments, and controlled release procedures.
- Experience supporting UAT, preparing simple process documentation, or providing user guidance and training.
- Interest in expanding Power Platform skills and improving business processes through low-code solutions.
REQUIRED SKILLS
- Application Configuration
- Business Requirements Documentation (BRD)
- Data Quality Management
- End User Communication
- Microsoft Dataverse
- Microsoft Power Platform
- Technical Troubleshooting
- Ticket Management
- User Acceptance Testing (UAT)
PREFERRED SKILLS
- Change Controls
- Microsoft Power BI
- Microsoft SharePoint
- Microsoft Teams
- Process Mapping
LOCATION
The primary location for this posting is:
USA - Pennsylvania - North Wales (Upper Gwynedd)
COMPENSATION
- The salary range for the primary location of this role is:
$106,200.00 - $167,200.00
This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts.
JOB POSTING END DATE
11/18/2026
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
REQUISITION ID
R424766
See all 265+ H-1B Visa Regulatory Affairs Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new H-1B Visa Regulatory Affairs Jobs.
Get Access To All JobsTips for Finding H-1B Visa Sponsorship in Regulatory Affairs
Align your degree to FDA submission work
USCIS scrutinizes whether your degree field directly supports the specific RA duties in the job description. A chemistry or biology degree paired with regulatory coursework strengthens specialty occupation arguments far more than a general science background.
Search LCA filings before applying anywhere
Use Migrate Mate to filter employers by verified DOL LCA filing history in Regulatory Affairs. This surfaces companies that have already demonstrated H-1B sponsorship intent for this job code, cutting your search time significantly.
Target employers with dedicated RA departments
Standalone RA departments at mid-size pharma and Class II medical device companies sponsor more consistently than generalist consulting firms. O*NET classifies Regulatory Affairs Specialists under SOC 13-1041, which you can cross-reference against OFLC disclosure data.
Negotiate LCA filing into your offer timeline
The DOL must certify your LCA before USCIS receives the I-129 petition. Ask your employer to begin the LCA at least three weeks before your intended start date so certification doesn't delay your H-1B effective date.
Document foreign regulatory experience for RFEs
If you've worked with EMA, Health Canada, or TGA submissions, get official employer letters specifying submission types and your exact role. USCIS RFEs on RA petitions frequently challenge whether non-U.S. experience maps to the specialty occupation standard.
Verify your employer's E-Verify enrollment status
H-1B employers must be E-Verify participants to request cap-exempt processing through certain institutions or to rehire H-1B workers portably. Confirm enrollment before your final offer acceptance, not after signing.
H-1B Visa Regulatory Affairs: Frequently Asked Questions
Does a Regulatory Affairs job qualify as an H-1B specialty occupation?
Yes. Regulatory Affairs Specialist roles require theoretical and practical application of life sciences, pharmacy, chemistry, or engineering knowledge at the bachelor's degree level or higher. USCIS has approved H-1B petitions for RA roles across pharma, biotech, and medical device sectors. The employer's job description must specify degree requirements that are directly related to RA duties, not just broadly preferred.
Which industries sponsor H-1B visas most often for Regulatory Affairs professionals?
Pharmaceutical manufacturers, biologics companies, Class II and Class III medical device firms, and CROs file the largest volume of H-1B LCAs for Regulatory Affairs roles. Biotech startups preparing for IND or NDA submissions also sponsor frequently because RA expertise is scarce domestically. You can browse employers with active H-1B filing history for this role category on Migrate Mate.
What happens to my H-1B status if my employer loses an FDA contract or restructures the RA team?
You have a 60-day grace period after involuntary termination to find new H-1B sponsorship, change to another status, or depart the U.S. Under AC21 portability rules, if your I-140 has been approved and your I-485 has been pending for 180 days or more, you can port to a same or similar RA role with a new employer without losing your priority date.
How does the prevailing wage requirement affect H-1B sponsorship for Regulatory Affairs roles?
Your employer must pay at least the DOL prevailing wage for the RA job title, level, and work location. Prevailing wages are set at four wage levels based on experience and complexity. You can look up the applicable wage yourself using the OFLC Wage Search before negotiations. Employers who underpay relative to the certified LCA wage risk DOL audit and back-pay liability.
Can I transfer my H-1B to a new Regulatory Affairs employer mid-sponsorship?
Yes. H-1B portability lets you start working for a new H-1B employer as soon as the new I-129 petition is filed, not after approval. The new role must be in the same or a substantially similar RA occupational classification. Your new employer files a new LCA and I-129; you don't restart the lottery. This makes lateral moves within RA feasible without status gaps.