OPT Regulatory Affairs Jobs
Regulatory Affairs jobs are a strong fit for OPT students with degrees in pharmacy, biology, chemistry, or engineering. Most roles 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 qualified regulatory professionals.
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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 Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new OPT Regulatory Affairs Jobs.
Get Access To All JobsTips for Finding OPT Sponsorship in Regulatory Affairs
Target regulated industries first
Pharma, biotech, and medical device companies have dedicated regulatory departments and established visa sponsorship pipelines. These employers understand OPT timelines and are far more likely to support H-1B petitions than companies outside regulated industries.
Confirm your degree qualifies for STEM OPT
Regulatory Affairs roles typically require a STEM-classified degree such as biology, chemistry, pharmaceutical sciences, or biomedical engineering. Confirm your CIP code with your DSO before applying, since STEM OPT extension eligibility determines whether you get 12 or 36 months of work authorization.
Highlight relevant regulatory experience upfront
Employers weigh FDA submission experience, quality systems knowledge, and familiarity with regulations like 21 CFR heavily. Feature these in your resume summary and cover letter so hiring managers immediately understand your technical fit before evaluating your visa status.
Ask about sponsorship during the recruiter screen
Raise your OPT status during the first recruiter call, not after an offer. Ask directly whether the company has sponsored H-1B visas for Regulatory Affairs roles before. This saves time and signals that you're organized and transparent about your work authorization situation.
Pursue RAC or RAC-P certification proactively
The Regulatory Affairs Certification credential signals professional commitment and reduces employer hesitation around sponsorship. OPT students who hold or are actively pursuing RAC certification stand out in competitive candidate pools, especially for entry-level and associate-level regulatory positions.
Track your OPT end date and plan around H-1B timelines
H-1B petitions must be filed by April 1 for an October 1 start date. If your OPT expires before October, your STEM extension and employer's cap-exempt status matter. Map your authorization window before accepting offers to avoid gaps in employment eligibility.
Regulatory Affairs OPT: Frequently Asked Questions
Can I work in Regulatory Affairs on OPT?
Yes. Regulatory Affairs roles are eligible for OPT as long as the position is directly related to your degree field. Most qualifying degrees, including pharmacy, biology, chemistry, and biomedical engineering, are STEM-classified, which means you may be eligible for the 24-month STEM OPT extension on top of your initial 12-month authorization period.
Do Regulatory Affairs employers commonly sponsor H-1B visas?
Yes, particularly in pharma, biotech, and medical device companies. Regulatory Affairs is a specialized technical function, and employers in these industries have well-established H-1B sponsorship processes. Smaller companies and contract research organizations may sponsor less frequently, so it's worth confirming sponsorship history before investing time in the interview process. Migrate Mate filters job listings by sponsorship willingness to help you find the right fit.
What degrees qualify for STEM OPT extension in Regulatory Affairs?
Degrees in pharmaceutical sciences, biology, chemistry, biochemistry, biomedical engineering, and related STEM fields typically qualify. Your degree's CIP code determines eligibility, not the job title itself. Confirm your CIP code with your Designated School Official before applying for the extension. A qualifying STEM degree gives you up to 36 total months of OPT work authorization, which significantly expands your H-1B sponsorship window.
How should I explain my OPT status to a Regulatory Affairs employer?
Be direct and factual during the recruiter screen. Explain that you're authorized to work on OPT, specify your authorization end date, and note whether you qualify for the STEM extension. Mention that you'll need H-1B sponsorship before OPT expires. Regulatory Affairs employers in pharma and biotech are accustomed to this conversation and generally respond well to candidates who are organized and proactive about it.
What types of Regulatory Affairs roles are most accessible for OPT students?
Entry-level and associate regulatory affairs specialist roles are the most accessible. Positions focused on document management, submissions coordination, regulatory intelligence, and quality system support often welcome candidates with relevant internship experience and STEM degrees. Senior roles typically require several years of direct FDA interaction experience. Browse current Regulatory Affairs openings on Migrate Mate to find roles that specifically welcome OPT candidates.