Regulatory Affairs Director Jobs in USA with Visa Sponsorship
Regulatory Affairs Directors qualify for H-1B visa, E-3 visa, TN visa, and EB-2 sponsorship because the role meets specialty occupation standards under U.S. immigration law. Employers in pharma, biotech, and medical device sectors regularly file LCAs for this title, making sponsored roles more accessible than in many other senior functions. For detailed occupation requirements, see the O*NET profile.
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Get Access To All JobsINTRODUCTION
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
ROLE AND RESPONSIBILITIES
The Director, Regulatory Affairs will be responsible for developing, implementing, and advising on North America (NA) regulatory strategies for development programs to secure and maintain market access in NA for product(s) in line with business objectives, and in coordination with the global regulatory leader and key internal stakeholders. This individual will manage NA regulatory aspects of compounds through all phases of development, post-approval, and life cycle of the product. The incumbent will provide leadership and strategic regulatory oversight from a NA perspective for designated projects ensuring that the latest requirements and standards are met. Externally, the individual will interface with outside regulatory agencies and more specifically, the FDA, and business partners regarding development, regulatory, and registration strategies within the US and Canada. The Director will also provide line management, people development, and performance management as well as support/lead development and implementation of department policies.
Essential Functions of the job:
- Provides high level regulatory strategic and operational direction for NA and mentorship on projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approval, regulatory strategic development plans and risk assessments, critical issue management and advice for the FDA and Health Canada interactions.
- Uses extensive knowledge of US regulatory requirements and applies this knowledge both strategically and operationally to development projects and marketed product regulatory issues to support corporate goals.
- Oversees the preparation and submission of documentation to support investigational and marketing registration packages within the US and Canada ensuring timelines are met in alignment with the global strategy as determined by the global regulatory leader.
- Reviews sections of the documents that will be utilized in the US and Canada in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements.
- Liaises and negotiates with the FDA and Health Canada as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite approvals of product and labeling changes.
- Maintains awareness of global regulatory environment and assess impact of changes on business and product development programs. Facilitate policy and development of standard interpretation of global regulation.
- Integrates functional expertise with business knowledge to solve problems and make good decisions for the overall business.
- Trains, develops, and manages an effective regional regulatory team both via direct and indirect reporting structure.
- Builds partnerships with senior key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge and expertise.
- Manages critical issues, taking leadership for the regulatory contribution.
- Responsible for assisting with the development and implementation of regulatory processes.
- Recruits, develops, manages, and mentors regulatory professionals and helps create a goal-oriented culture.
Supervisory Responsibilities:
Some supervisory responsibilities for multi-level regulatory team(s).
COMPUTER SKILLS
- Experience with Microsoft Office suite
- Veeva regulatory publishing
- PowerPoint presentation authoring and presentation
BASIC QUALIFICATIONS
- 10+ years of experience in the biotechnical or pharmaceutical industry, and a minimum of 5 years’ experience in a Regulatory capacity with a broad background.
- Bachelor’s degree required; advanced degree preferred.
- Preferred candidates will have experience working as a lead in Regulatory Affairs with the FDA and prior experience with both small molecules and biologics.
- Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends.
- Extensive regulatory experience with INDs/CTAs, NDAs/BLAs, lifecycle management, interactions with Health Authorities, leading and managing regulatory teams, developing and implementing regulatory strategies with a proven track record of significant regulatory accomplishments.
- Strong business acumen and ability to make sound decisions that contribute positively to the business.
- Very strong strategic skills including creativity and effectiveness in identifying and addressing major strategic challenges (e.g., new competition, shifting market environment) and the ability to balance short-term needs with long-term vision.
- Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism.
- Excellent verbal and written skills; Able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to be internal and external stakeholders.
- Skilled in conflict resolution/negotiation. Fosters open communication. Listens and facilitates discussion.
- Strong negotiating skills and ability to think creatively and develop creative solutions.
- Proven ability to build trust and respect within the organization.
- Ability to prioritize and handle multiple projects simultaneously.
- Interacts with external business partners and Regulatory Agencies.
- Proven ability to build trust and respect within the organization.
- Ability to prioritize and handle multiple projects simultaneously.
TRAVEL
Business travel to be 10-20% as required.
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity
COMPENSATION
- Salary Range: $176,000.00 - $236,000.00 annually
BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.
INTRODUCTION
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
ROLE AND RESPONSIBILITIES
The Director, Regulatory Affairs will be responsible for developing, implementing, and advising on North America (NA) regulatory strategies for development programs to secure and maintain market access in NA for product(s) in line with business objectives, and in coordination with the global regulatory leader and key internal stakeholders. This individual will manage NA regulatory aspects of compounds through all phases of development, post-approval, and life cycle of the product. The incumbent will provide leadership and strategic regulatory oversight from a NA perspective for designated projects ensuring that the latest requirements and standards are met. Externally, the individual will interface with outside regulatory agencies and more specifically, the FDA, and business partners regarding development, regulatory, and registration strategies within the US and Canada. The Director will also provide line management, people development, and performance management as well as support/lead development and implementation of department policies.
Essential Functions of the job:
- Provides high level regulatory strategic and operational direction for NA and mentorship on projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approval, regulatory strategic development plans and risk assessments, critical issue management and advice for the FDA and Health Canada interactions.
- Uses extensive knowledge of US regulatory requirements and applies this knowledge both strategically and operationally to development projects and marketed product regulatory issues to support corporate goals.
- Oversees the preparation and submission of documentation to support investigational and marketing registration packages within the US and Canada ensuring timelines are met in alignment with the global strategy as determined by the global regulatory leader.
- Reviews sections of the documents that will be utilized in the US and Canada in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements.
- Liaises and negotiates with the FDA and Health Canada as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite approvals of product and labeling changes.
- Maintains awareness of global regulatory environment and assess impact of changes on business and product development programs. Facilitate policy and development of standard interpretation of global regulation.
- Integrates functional expertise with business knowledge to solve problems and make good decisions for the overall business.
- Trains, develops, and manages an effective regional regulatory team both via direct and indirect reporting structure.
- Builds partnerships with senior key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge and expertise.
- Manages critical issues, taking leadership for the regulatory contribution.
- Responsible for assisting with the development and implementation of regulatory processes.
- Recruits, develops, manages, and mentors regulatory professionals and helps create a goal-oriented culture.
Supervisory Responsibilities:
Some supervisory responsibilities for multi-level regulatory team(s).
COMPUTER SKILLS
- Experience with Microsoft Office suite
- Veeva regulatory publishing
- PowerPoint presentation authoring and presentation
BASIC QUALIFICATIONS
- 10+ years of experience in the biotechnical or pharmaceutical industry, and a minimum of 5 years’ experience in a Regulatory capacity with a broad background.
- Bachelor’s degree required; advanced degree preferred.
- Preferred candidates will have experience working as a lead in Regulatory Affairs with the FDA and prior experience with both small molecules and biologics.
- Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends.
- Extensive regulatory experience with INDs/CTAs, NDAs/BLAs, lifecycle management, interactions with Health Authorities, leading and managing regulatory teams, developing and implementing regulatory strategies with a proven track record of significant regulatory accomplishments.
- Strong business acumen and ability to make sound decisions that contribute positively to the business.
- Very strong strategic skills including creativity and effectiveness in identifying and addressing major strategic challenges (e.g., new competition, shifting market environment) and the ability to balance short-term needs with long-term vision.
- Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism.
- Excellent verbal and written skills; Able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to be internal and external stakeholders.
- Skilled in conflict resolution/negotiation. Fosters open communication. Listens and facilitates discussion.
- Strong negotiating skills and ability to think creatively and develop creative solutions.
- Proven ability to build trust and respect within the organization.
- Ability to prioritize and handle multiple projects simultaneously.
- Interacts with external business partners and Regulatory Agencies.
- Proven ability to build trust and respect within the organization.
- Ability to prioritize and handle multiple projects simultaneously.
TRAVEL
Business travel to be 10-20% as required.
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity
COMPENSATION
- Salary Range: $176,000.00 - $236,000.00 annually
BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.
See all 749+ Regulatory Affairs Director Jobs
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Get Access To All JobsTips for Finding Regulatory Affairs Director Jobs
Map your degree to the role
Regulatory affairs sits at the intersection of science, law, and compliance. USCIS expects your degree to be in a directly related field, life sciences, pharmacy, chemistry, or biomedical engineering. A general business degree alone will likely trigger an RFE.
Target PERM-active pharma and biotech employers
Companies running active PERM labor certifications for RA directors signal long-term green card pathways. Search OFLC public disclosure data filtered by job title and NAICS code to identify which employers in your specialty are actively sponsoring permanent residence.
Use Migrate Mate to find verified sponsors
Filter for Regulatory Affairs Director roles on Migrate Mate, which lists employers with verified LCA filing history. This saves you from applying to companies that have never sponsored the title and focuses your search on active sponsoring employers in pharma and device sectors.
Clarify TN eligibility before negotiating offers
If you're a Canadian or Mexican national, the TN visa covers scientists and engineers but not a general 'director' title. Confirm with your prospective employer that your offer letter frames the role around a qualifying USMCA profession before you enter negotiations.
Get your international credentials pre-evaluated
Foreign degrees from regulatory science programs outside the U.S. need a credential evaluation before your employer files the LCA. A NACES-member evaluator's report confirming bachelor's equivalency prevents delays when the DOL reviews the specialty occupation attestation.
Negotiate who covers the LCA prevailing wage tier
The LCA locks your wage to a DOL prevailing wage level for the role's location. Run the OFLC Wage Search for your specific metro area and job zone before your offer conversation so you understand the floor your employer must meet and can negotiate above it.
Frequently Asked Questions
Does a Regulatory Affairs Director role qualify as a specialty occupation for H-1B purposes?
Yes. Regulatory Affairs Director is widely accepted as a specialty occupation because the role normally requires at least a bachelor's degree in a directly related field such as life sciences, pharmacy, or biomedical engineering. USCIS evaluates the specific job duties, so your offer letter should tie the degree requirement explicitly to the core responsibilities, not describe it as preferred or a substitute for experience.
Which visa types can sponsor a Regulatory Affairs Director position?
H-1B is the most common path and requires an employer to file an LCA with DOL and an I-129 petition with USCIS. Australian nationals can use the E-3, which follows the same specialty occupation standard but is not subject to the H-1B lottery. Canadian and Mexican nationals may qualify under TN if the role maps to a USMCA-listed profession. Employers pursuing long-term retention typically sponsor EB-2 green cards through PERM labor certification.
How do I find employers who actively sponsor Regulatory Affairs Director roles?
Migrate Mate lists employers with verified LCA filing history for regulatory affairs titles, so you can focus your applications on companies that have actually sponsored the role rather than guessing from job postings. Pharma, biotech, and medical device companies represent the highest concentration of active sponsors for this title.
Does a three-year Australian or European degree qualify for H-1B specialty occupation purposes?
USCIS generally accepts three-year bachelor's degrees from Australia and many European institutions as equivalent to a U.S. four-year degree, particularly when combined with relevant postgraduate credentials or substantial professional experience. A formal credential evaluation from a NACES-member organization before your employer files the LCA protects against an RFE challenging degree equivalency mid-petition.
Can a Regulatory Affairs Director on H-1B change employers without losing status?
Yes. H-1B portability allows you to start with a new employer once the new I-129 petition is filed with USCIS, without waiting for approval. If you're also in a PERM or I-140 green card process, the AC21 portability provision under the Immigration and Nationality Act lets you carry an approved I-140 priority date to a new employer after 180 days, as long as the new role is in the same or similar occupational classification.
What is the prevailing wage requirement for sponsored Regulatory Affairs Director jobs?
U.S. employers sponsoring a visa must pay at least the prevailing wage, which is what workers in the same role, area, and experience level typically earn. The Department of Labor sets this rate to make sure companies aren't hiring foreign workers simply because they'd accept lower pay than a U.S. worker. It varies by job title, location, and experience. You can look up current prevailing wage rates for any occupation and location using the OFLC Wage Search page.