H-1B Visa Regulatory Affairs Manager Jobs
Regulatory Affairs Managers qualify for H-1B sponsorship as a specialty occupation requiring a bachelor's degree or higher in a directly related field such as regulatory science, pharmacy, or life sciences. Pharma, biotech, and medical device companies sponsor heavily for this role, and the work spans FDA submissions, compliance strategy, and cross-functional product approvals.
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Get Access To All JobsResponsibilities:
- Support the Senior Director in developing and executing regional regulatory strategies for QOL initiatives within specific regions.
- Contribute to providing strategic oversight and leadership to the regulatory team, ensuring alignment with company objectives and regional regulatory requirements.
- Participate in the preparation and submission of regulatory documents related to QOL initiatives to regulatory authorities.
- Collaborate with cross-functional teams to integrate QOL considerations into product development, manufacturing, and commercialization processes.
- Assist in fostering relationships with regional regulatory authorities to facilitate communication, negotiations, and interactions related to QOL initiatives.
- Stay informed about regulatory developments, changes, and trends within specific regions, and provide insights to the Senior Director and Associate Director.
- Contribute to managing regulatory risks and opportunities related to QOL initiatives and assist in developing mitigation strategies as needed.
- Provide regulatory guidance and support for post-marketing activities related to QOL initiatives, including variations, renewals, labeling updates, and compliance initiatives.
- Collaborate with the regulatory team to represent the company's interests in industry forums, working groups, and regulatory meetings related to QOL initiatives.
- Support coordination with global regulatory counterparts to ensure alignment of regional regulatory strategies and submissions with global development plans and corporate objectives.
- Assist in preparing regulatory updates, progress reports, and strategic recommendations for senior and/or executive leadership and regulatory governance committees.
- Assist in preparing and organizing all necessary documentation required for regulatory inspections and inspection readiness initiatives, ensuring completeness, accuracy, and accessibility of records related to QOL initiatives.
- Participate in facilitating communication, providing requested documentation, and addressing any questions or concerns raised by the inspection readiness team in a timely and professional manner.
Requirements
- Bachelor's degree in a scientific discipline such as life sciences, pharmacy, bioscience; advanced degree preferred.
- 5+ years of experience in regulatory affairs within the pharmaceutical or biotech industry, with a focus on quality-of-life products preferred.
- Must have branded product reg affairs experience.
- Demonstrated ability to work effectively in a cross-functional team environment.
- Strong knowledge of regional regulatory requirements and guidelines, including FDA regulations and ICH guidelines.
- Excellent communication and interpersonal skills.
- Ability to assist in developing and executing regulatory strategies tailored to specific regions.
- Strong organizational skills with attention to detail.
- Ability to collaborate effectively with cross-functional teams.
- Knowledge of regulatory submissions and documentation processes.
- Awareness of regulatory developments and trends within specific regions.
- Strong analytical and problem-solving skills.
- Ability to work independently and prioritize tasks effectively.
- Ability and willingness to travel approximately 10% of the year both domestically and internationally.
Responsibilities:
- Support the Senior Director in developing and executing regional regulatory strategies for QOL initiatives within specific regions.
- Contribute to providing strategic oversight and leadership to the regulatory team, ensuring alignment with company objectives and regional regulatory requirements.
- Participate in the preparation and submission of regulatory documents related to QOL initiatives to regulatory authorities.
- Collaborate with cross-functional teams to integrate QOL considerations into product development, manufacturing, and commercialization processes.
- Assist in fostering relationships with regional regulatory authorities to facilitate communication, negotiations, and interactions related to QOL initiatives.
- Stay informed about regulatory developments, changes, and trends within specific regions, and provide insights to the Senior Director and Associate Director.
- Contribute to managing regulatory risks and opportunities related to QOL initiatives and assist in developing mitigation strategies as needed.
- Provide regulatory guidance and support for post-marketing activities related to QOL initiatives, including variations, renewals, labeling updates, and compliance initiatives.
- Collaborate with the regulatory team to represent the company's interests in industry forums, working groups, and regulatory meetings related to QOL initiatives.
- Support coordination with global regulatory counterparts to ensure alignment of regional regulatory strategies and submissions with global development plans and corporate objectives.
- Assist in preparing regulatory updates, progress reports, and strategic recommendations for senior and/or executive leadership and regulatory governance committees.
- Assist in preparing and organizing all necessary documentation required for regulatory inspections and inspection readiness initiatives, ensuring completeness, accuracy, and accessibility of records related to QOL initiatives.
- Participate in facilitating communication, providing requested documentation, and addressing any questions or concerns raised by the inspection readiness team in a timely and professional manner.
Requirements
- Bachelor's degree in a scientific discipline such as life sciences, pharmacy, bioscience; advanced degree preferred.
- 5+ years of experience in regulatory affairs within the pharmaceutical or biotech industry, with a focus on quality-of-life products preferred.
- Must have branded product reg affairs experience.
- Demonstrated ability to work effectively in a cross-functional team environment.
- Strong knowledge of regional regulatory requirements and guidelines, including FDA regulations and ICH guidelines.
- Excellent communication and interpersonal skills.
- Ability to assist in developing and executing regulatory strategies tailored to specific regions.
- Strong organizational skills with attention to detail.
- Ability to collaborate effectively with cross-functional teams.
- Knowledge of regulatory submissions and documentation processes.
- Awareness of regulatory developments and trends within specific regions.
- Strong analytical and problem-solving skills.
- Ability to work independently and prioritize tasks effectively.
- Ability and willingness to travel approximately 10% of the year both domestically and internationally.
See all 81+ Regulatory Affairs Manager jobs
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Get Access To All JobsTips for Finding H-1B Visa Sponsorship as a Regulatory Affairs Manager
Align your credentials to specialty occupation requirements
USCIS evaluates whether your degree field directly relates to regulatory affairs work. A degree in regulatory science, pharmacy, chemistry, or biomedical engineering strengthens your petition far more than a general business degree, even with years of relevant experience.
Target employers with active LCA filing history
Search Migrate Mate to filter Regulatory Affairs Manager roles by employers who have filed Labor Condition Applications for this occupation. LCA history confirms an employer has already navigated DOL prevailing wage requirements for your exact job category.
Verify your role's SOC code before accepting an offer
Regulatory Affairs Managers are typically classified under SOC 11-9199 or 11-1021 depending on the employer. The SOC code determines the prevailing wage tier DOL uses, so confirm your employer's classification matches your actual duties before the LCA is filed.
Ask about cap-exempt employer status during interviews
Hospitals, universities, and certain nonprofit research institutions attached to higher education can sponsor H-1B visas outside the annual lottery cap. Regulatory affairs roles at academic medical centers or NIH-affiliated labs may let you skip the lottery entirely.
Use O*NET to document specialty occupation evidence
O*NET lists the typical education and knowledge requirements for regulatory affairs occupations. Print or save this profile before your petition is filed. Employers and attorneys use it to demonstrate that a bachelor's in a specific field is standard for the role.
Request premium processing if product timelines are tight
Regulatory affairs roles often tie directly to product launch or FDA submission deadlines. USCIS premium processing adjudicates the I-129 petition within 15 business days. Ask your employer to include it if your start date aligns with a critical regulatory milestone.
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Find Regulatory Affairs Manager JobsRegulatory Affairs Manager H-1B Visa: Frequently Asked Questions
Does a Regulatory Affairs Manager role qualify as a specialty occupation for H-1B purposes?
Yes. USCIS recognizes Regulatory Affairs Manager as a specialty occupation because the role typically requires a bachelor's degree or higher in a field such as regulatory science, pharmacy, chemistry, or a related life sciences discipline. Employers must document in the LCA and I-129 petition that the position demands specialized theoretical and practical knowledge tied to a specific degree field.
Which industries sponsor H-1B visas most consistently for Regulatory Affairs Managers?
Pharmaceutical, biotechnology, and medical device companies account for the largest share of H-1B sponsorships for this role, driven by FDA submission requirements and ongoing compliance obligations. Contract research organizations and in vitro diagnostics firms also sponsor regularly. You can browse verified sponsoring employers filtered by this job title on Migrate Mate.
How does the prevailing wage requirement affect Regulatory Affairs Manager H-1B filings?
Your employer must pay at least the DOL prevailing wage for a Regulatory Affairs Manager in the specific metropolitan area where you'll work. Wages are tiered by experience level, and the employer certifies this on the LCA before filing the H-1B petition. You can look up applicable wage levels by location and SOC code using the OFLC Wage Search.
Can a Regulatory Affairs Manager change employers while on H-1B status?
Yes, through H-1B portability under AC21. Once your initial H-1B petition has been approved and you've worked for the sponsoring employer, a new employer can file an H-1B transfer petition and you can begin work as soon as the receipt notice is issued. The new role must still qualify as a specialty occupation in regulatory affairs.
What documentation strengthens an H-1B petition for a Regulatory Affairs Manager role?
Strong petitions include a detailed job description specifying FDA regulatory submissions, compliance programs, or device approval processes; official transcripts showing a degree in a relevant field; and an employer letter explaining why the position requires that specific degree. If your title varies by employer, the O*NET occupation profile for this role category can serve as supporting evidence of degree-level requirements.
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