OPT Regulatory Affairs Specialist Jobs
Regulatory Affairs Specialist roles are a strong fit for F-1 OPT students with degrees in life sciences, pharmacy, 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 H-1B visas for 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 Specialist Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new OPT Regulatory Affairs Specialist Jobs.
Get Access To All JobsTips for Finding OPT Sponsorship as a Regulatory Affairs Specialist
Target regulated industries first
Pharma, biotech, and medical device companies have dedicated regulatory departments and are accustomed to visa sponsorship. These employers file H-1B petitions regularly, making them far more likely to extend your OPT into full sponsorship than general employers.
Confirm your degree qualifies for STEM OPT
Regulatory Affairs roles typically qualify for the 24-month STEM OPT extension if your degree is in biology, chemistry, pharmacy, or a related field. Verify your CIP code with your DSO before applying so you know your full authorization window upfront.
Highlight regulatory database experience on your resume
Familiarity with FDA submission systems, eCTD formatting, or ICH guidelines signals job-readiness to hiring managers. Specific technical knowledge reduces employer hesitation about the time investment required to train an OPT hire before sponsorship becomes relevant.
Ask about H-1B sponsorship before accepting an offer
Regulatory Affairs positions are specialty occupations that meet H-1B criteria, but not every employer actively sponsors. Confirm willingness to sponsor during the offer stage, not after you've started, so you can plan your immigration timeline without surprises.
Apply early relative to your OPT end date
H-1B cap-subject petitions must be filed in April for an October 1 start. If your OPT expires before October, your employer may need to request a cap-gap extension. Start your job search at least six months before your OPT authorization ends.
Pursue RAC or RAPS certification if you're early career
The Regulatory Affairs Certification from RAPS signals credibility in a field where credentials matter. Even pursuing coursework demonstrates commitment to the profession, which can reassure employers considering the additional overhead of sponsoring a work visa.
Regulatory Affairs Specialist OPT: Frequently Asked Questions
Does a Regulatory Affairs Specialist role qualify for the STEM OPT extension?
Yes, in most cases. If your undergraduate or graduate degree is in a STEM field such as biology, chemistry, pharmaceutical sciences, or biomedical engineering, your role will typically qualify for the 24-month STEM OPT extension. Confirm your degree's CIP code with your DSO, since the extension is tied to your degree classification, not the job title itself.
Is Regulatory Affairs Specialist considered a specialty occupation for H-1B purposes?
Yes. Regulatory Affairs Specialist positions generally qualify as specialty occupations under H-1B rules because they require at minimum a bachelor's degree in a specific field such as life sciences, chemistry, or pharmacy. USCIS has consistently approved H-1B petitions for this role when the degree requirement is clearly documented in the job description and employer attestation.
Which types of employers are most likely to sponsor OPT students in regulatory affairs?
Pharmaceutical companies, biotechnology firms, medical device manufacturers, and contract research organizations are the most active sponsors for this role. These companies operate under FDA oversight and maintain in-house regulatory teams that file H-1B petitions routinely. You can browse OPT-friendly regulatory affairs openings directly on Migrate Mate, which filters for employers open to sponsorship.
What happens if my OPT expires before the H-1B October 1 start date?
If your employer files an H-1B petition on your behalf before your OPT expires, you're covered by cap-gap protection, which automatically extends your work authorization through September 30. Your employer must file before your OPT end date for cap-gap to apply. Work with your DSO and employer's immigration counsel to confirm the filing timeline well in advance.
Do I need to disclose my OPT status when applying for Regulatory Affairs roles?
You don't have to disclose it upfront in your application, but employers will ask about work authorization status before extending an offer. Being prepared to explain your OPT timeline, STEM extension eligibility, and H-1B sponsorship needs clearly and confidently tends to reduce employer hesitation. Framing your remaining authorization window accurately helps employers assess whether the timeline works for their hiring plans.