OPT Regulatory Affairs Lead Jobs
Regulatory Affairs Lead roles are a strong fit for F-1 OPT students with backgrounds in life sciences, chemistry, or engineering. Most positions qualify as STEM OPT extensions, giving you up to 36 months of work authorization. Employers in pharma, biotech, and medical devices regularly sponsor this role.
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Summary:
The Program Manager Health Plans Regulatory Affairs role is to assist in the implementation and maintenance of the CHRISTUS Health Compliance Program. This job assists the Regulatory Affairs team in the execution of established work priorities and plans, management, and monitoring of operational compliance related tasks. These tasks are to include internal auditing and monitoring activities, external audit coordination, and regulatory training and education.
Responsibilities:
- Meets expectations of the applicable OneCHRISTUS Competencies: Leader of Self, Leader of Others, or Leader of Leaders.
- Review and research laws and regulations both on a reactive and proactive basis to ensure an effective and accurate response to legal and regulatory compliance for Medicare Advantage and Health Exchange lines of business.
- Monitors Health Plan progress in resolution of issues identified through the Risk Assessment and Monitoring Work Plan and internal and external audit findings.
- Analyze and periodically report on risk-related trends to the Compliance Committee to ensure organizational awareness of potential noncompliance.
- Perform ongoing internal monitoring/audits based on risk level.
- Support implementation of consistent processes to enhance compliance within day-to-day health plan operations.
- Provide specialized education and development of materials as requested.
- Follow up with Action items necessary related to various audit requests and compliance related issues.
- Work with the regulatory affairs team to develop streamlined approaches between lines of business.
- Cross-train the regulatory affairs team on compliance related tasks to ensure operational compliance goals are met.
- Excellent interpersonal skills with regular interaction and communication with the Senior Leadership team and other associates within the organization.
- Ability to facilitate the resolution of issues and concerns that create barriers to a high-performing team and work environment.
- Ability to manage project/monitoring work plans for achieving project goals and objectives.
- Coordinates assigned projects, including monitoring projects to present to leadership and regulatory bodies.
- Serves as Project Manager on external compliance audits conducted by regulatory bodies.
- Serves as a resource in regulatory guidance for Health Exchange and Medicare Lines of Business.
- Performs other duties as assigned.
Job Requirements:
Education/Skills
- Bachelor's Degree in Related Field of Study and or equivalent years of work experience required
Experience
- 4 - 6 years of related experience preferred
Licenses, Registrations, or Certifications
- None required
In accordance with the CHRISTUS Health License, Certification and Registration Verification Policy, all Associates are required to obtain the required certifications for their respective positions within the designated time frame.
Work Schedule:
8AM - 5PM Monday-Friday
Work Type:
Full Time
Description
Summary:
The Program Manager Health Plans Regulatory Affairs role is to assist in the implementation and maintenance of the CHRISTUS Health Compliance Program. This job assists the Regulatory Affairs team in the execution of established work priorities and plans, management, and monitoring of operational compliance related tasks. These tasks are to include internal auditing and monitoring activities, external audit coordination, and regulatory training and education.
Responsibilities:
- Meets expectations of the applicable OneCHRISTUS Competencies: Leader of Self, Leader of Others, or Leader of Leaders.
- Review and research laws and regulations both on a reactive and proactive basis to ensure an effective and accurate response to legal and regulatory compliance for Medicare Advantage and Health Exchange lines of business.
- Monitors Health Plan progress in resolution of issues identified through the Risk Assessment and Monitoring Work Plan and internal and external audit findings.
- Analyze and periodically report on risk-related trends to the Compliance Committee to ensure organizational awareness of potential noncompliance.
- Perform ongoing internal monitoring/audits based on risk level.
- Support implementation of consistent processes to enhance compliance within day-to-day health plan operations.
- Provide specialized education and development of materials as requested.
- Follow up with Action items necessary related to various audit requests and compliance related issues.
- Work with the regulatory affairs team to develop streamlined approaches between lines of business.
- Cross-train the regulatory affairs team on compliance related tasks to ensure operational compliance goals are met.
- Excellent interpersonal skills with regular interaction and communication with the Senior Leadership team and other associates within the organization.
- Ability to facilitate the resolution of issues and concerns that create barriers to a high-performing team and work environment.
- Ability to manage project/monitoring work plans for achieving project goals and objectives.
- Coordinates assigned projects, including monitoring projects to present to leadership and regulatory bodies.
- Serves as Project Manager on external compliance audits conducted by regulatory bodies.
- Serves as a resource in regulatory guidance for Health Exchange and Medicare Lines of Business.
- Performs other duties as assigned.
Job Requirements:
Education/Skills
- Bachelor's Degree in Related Field of Study and or equivalent years of work experience required
Experience
- 4 - 6 years of related experience preferred
Licenses, Registrations, or Certifications
- None required
In accordance with the CHRISTUS Health License, Certification and Registration Verification Policy, all Associates are required to obtain the required certifications for their respective positions within the designated time frame.
Work Schedule:
8AM - 5PM Monday-Friday
Work Type:
Full Time
See all 72+ OPT Regulatory Affairs Lead Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new OPT Regulatory Affairs Lead Jobs.
Get Access To All JobsTips for Finding OPT Sponsorship in Regulatory Affairs Lead
Target STEM-designated programs
Regulatory Affairs Lead roles typically qualify for the 24-month STEM OPT extension when your degree is in life sciences, chemistry, or engineering. Confirm your degree's CIP code with your DSO before applying to maximize your authorized work period.
Focus on regulated industries
Pharma, biotech, medical device, and food safety companies hire Regulatory Affairs Leads regularly and have established immigration infrastructure. These employers are far more familiar with OPT work authorization than companies in unregulated sectors, reducing friction during hiring.
Highlight submission experience precisely
List specific regulatory submissions you've contributed to, such as 510(k), NDA, BLA, or PMA filings. Employers hiring for a lead role need evidence you can own a submission independently, not just support one.
Address OPT timing proactively
Bring up your OPT end date and STEM extension eligibility early in the process. Regulatory Affairs hiring cycles can run three to six months, and employers need to plan H-1B visa sponsorship timelines around your current authorization window.
Demonstrate knowledge of multiple regulatory bodies
Familiarity with FDA, EMA, Health Canada, or TGA frameworks signals you can support international submissions. Cross-border regulatory experience is increasingly valued and can differentiate your application from candidates with single-agency backgrounds.
Pursue relevant professional credentials
The RAC credential from RAPS is widely recognized and signals regulatory competency to hiring managers. Obtaining or actively pursuing it during OPT strengthens your candidacy and demonstrates commitment to the field beyond your academic background.
Regulatory Affairs Lead OPT: Frequently Asked Questions
Do Regulatory Affairs Lead jobs qualify for the STEM OPT extension?
Most do, but it depends on your underlying degree rather than the job title itself. If your degree carries a STEM-designated CIP code in fields like chemistry, biology, or engineering, and the employer meets the E-Verify requirement, you can apply for the 24-month STEM OPT extension, giving you up to 36 months total. Confirm eligibility with your DSO before accepting an offer.
How do I find Regulatory Affairs Lead roles that are open to OPT students?
Migrate Mate filters job listings specifically for visa-friendly employers, so you can browse Regulatory Affairs Lead openings without wading through postings that exclude work authorization holders. Pharma, biotech, and medical device companies are the most active hirers for this role and are generally experienced with OPT documentation requirements.
Will employers sponsor an H-1B after my OPT ends for this role?
Regulatory Affairs Lead is classified as a specialty occupation under USCIS guidelines because it requires a specific scientific or technical degree, which makes H-1B sponsorship a realistic path. Large pharma and medical device companies sponsor this role regularly. Smaller companies may be willing but less experienced with the process, so it's worth asking directly during interviews.
What should I know about the 60-day grace period if a Regulatory Affairs Lead job falls through?
If your employment ends before your OPT period expires, you have a 60-day grace period to find new employment, transfer to a new visa status, or depart the United States. You cannot work during this window. Given that Regulatory Affairs hiring cycles can take several months, notify your DSO immediately so you can plan your next steps before the clock runs out.
Is a Regulatory Affairs Lead role considered a specialty occupation for OPT purposes?
OPT itself doesn't use the specialty occupation standard, but the role must be directly related to your field of study to qualify as authorized OPT employment. A Regulatory Affairs Lead position drawing on your chemistry, pharmacy, or biomedical engineering degree clearly satisfies this. Your DSO can confirm the match between your CIP code and the role's requirements if you need documentation.