H-1B Visa Regulatory Affairs Lead Jobs
Regulatory Affairs Lead roles qualify as H-1B visa specialty occupations under DOL's prevailing wage framework, requiring a bachelor's degree or higher in a directly related field such as regulatory science, chemistry, or life sciences. Employers in pharma, biotech, and medical devices sponsor H-1B petitions for this title regularly, and cap-exempt institutions add filing options outside the annual lottery.
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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 Lead Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new H-1B Visa Regulatory Affairs Lead Jobs.
Get Access To All JobsTips for Finding H-1B Visa Sponsorship in Regulatory Affairs Lead
Align your credentials to specialty occupation standards
USCIS evaluates whether your degree field directly relates to regulatory affairs. A chemistry, biology, or pharmaceutical sciences degree strengthens your petition. If your degree is in an adjacent field, document how your coursework maps to the core duties of a Regulatory Affairs Lead.
Target cap-exempt employers first
Hospitals, nonprofits attached to research institutions, and universities can file H-1B petitions year-round without lottery exposure. Regulatory affairs roles at academic medical centers or nonprofit research organizations qualify, cutting your wait from a full fiscal year to weeks.
Search LCA filing history on Migrate Mate
Filter by SOC code 13-1041 to see which pharma, biotech, and medical device employers have active Labor Condition Applications for regulatory roles. Employers with recent filings have confirmed infrastructure and willingness to sponsor, not just stated openness.
Verify prevailing wage tier before negotiating an offer
Pull the OFLC Wage Search for SOC 13-1041 in your target metro before accepting. Your employer's LCA must certify at least the Level II wage for your experience. Knowing the floor protects you from offers that create compliance risk at filing.
Confirm the employer's I-9 and E-Verify readiness
STEM OPT employers must be E-Verify enrolled, and many regulated pharma or device companies already are. Ask HR whether they're enrolled before the offer stage. Gaps in E-Verify enrollment delay your I-9 completion and complicate the transition from OPT to H-1B status.
Request premium processing if your OPT end date is close
USCIS adjudicates premium processing petitions within 15 business days. If your OPT expires within 60 days of your H-1B start date, ask your employer to elect premium processing so your approval arrives before you lose authorization to work.
H-1B Visa Regulatory Affairs Lead: Frequently Asked Questions
Does a Regulatory Affairs Lead role qualify as an H-1B specialty occupation?
Yes. USCIS classifies regulatory affairs positions as specialty occupations because the duties require at least a bachelor's degree in a directly related field such as regulatory science, life sciences, chemistry, or pharmacy. The O*NET profile for Regulatory Affairs Specialists supports this classification, and most employers use SOC code 13-1041 when filing the Labor Condition Application with DOL.
Which industries sponsor H-1B visas most consistently for Regulatory Affairs Lead positions?
Pharmaceutical manufacturers, biotech firms, and medical device companies sponsor the highest volume of H-1B petitions for regulatory affairs roles. Contract research organizations and in vitro diagnostics companies also file regularly. You can see which employers have active Labor Condition Applications for this role category by searching Migrate Mate, which surfaces DOL filing data by occupation and employer.
Can I transfer my H-1B to a new employer if my Regulatory Affairs Lead role changes scope?
Yes, H-1B portability under AC21 lets you start working for a new employer as soon as your transfer petition is filed, not after it's approved, provided your original petition has been approved and you've maintained valid status. If the new role involves materially different duties, your employer's attorney should document the specialty occupation basis again to avoid an RFE.
Does regulatory affairs work at a nonprofit hospital or university avoid the H-1B lottery?
It can. Cap-exempt status applies to H-1B petitions filed by qualifying nonprofits affiliated with research institutions and certain universities. If a hospital or academic medical center employs you in a Regulatory Affairs Lead capacity and meets the cap-exemption criteria under USCIS rules, your petition bypasses the lottery entirely and can be filed at any time of year.
What documentation does my employer need to file an H-1B petition for a Regulatory Affairs Lead role?
Your employer needs a certified Labor Condition Application from DOL, which covers prevailing wage compliance for the role's SOC code and work location. They'll also file Form I-129 with USCIS, supported by a detailed job duties letter, your academic credentials, and any professional licenses relevant to the regulatory function. Employers in FDA-regulated industries often already have H-1B filing experience, which accelerates the process.