Green Card Senior Director Regulatory Affairs Jobs
Senior Director Regulatory Affairs roles qualify for EB-2 sponsorship when they require an advanced degree in a life sciences or regulatory discipline, and many large pharmaceutical, biotech, and medical device employers run active PERM pipelines for this title. Your path to a green card starts with finding an employer already set up to sponsor.
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Get Access To All JobsSUMMARY/JOB PURPOSE:
Responsible for driving the development and implementation of global regulatory strategies that align with asset and corporate goals as well as health authority requirements. Ensures timely preparation of organized, consistent, and scientifically valid submissions. Provides expertise in translating regulatory requirements into practical, workable plans. Communicates clearly and proactively with stakeholders to reduce regulatory risk and drive the implementation of appropriate mitigation strategies.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Interact directly with regulatory authorities.
- Conduct effective and timely regulatory intelligence and research to provide guidance to study and asset teams. Provide risk assessments and recommendations for various regulatory scenarios, including possible expedited pathways.
- Represent Regulatory Affairs in multi-disciplinary teams to establish development and regulatory strategies for early and late-stage development programs.
- Work with external vendors to plan, review, prepare, submit, and maintain CTAs in Europe, Asia, and other regions.
- Review clinical trial-related documentation (e.g., protocols, informed consents, clinical study reports) for compliance with regulatory guidance and alignment with study objectives and regulatory strategy.
- Lead, author and evaluate documents submitted to regulatory health authorities to ensure they are complete, organized, of high quality, contain appropriate messaging and compliant with applicable regional regulations.
- Oversee the preparation and completion of regulatory submissions (electronic and paper), including investigational new drug applications, supplements and amendments, IND safety reports, annual reports/DSURs, other routine amendments, and new drug applications (NDA)/biologics license applications (BLA).
- Contribute to the implementation of processes and procedures, including developing and authoring internal work instructions and company SOPs.
- Lead multiple assets and/or studies as assigned.
SUPERVISORY RESPONSIBILITIES:
- Directly supervise employees.
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:
- Bachelor’s degree in related discipline and a minimum of fifteen years of related experience; or,
- Master’s degree in related discipline and a minimum of thirteen years of related experience; or,
- PhD degree in related discipline and a minimum of twelve years of related experience; or,
- Equivalent combination of education and experience.
Experience/The Ideal for Successful Entry into Job:
Knowledge/Skills:
- Develops and manages plans, establishes timelines, sets standards for performance. Manages and effectively communicates priorities. Motivates self and others to achieve business objectives and deliver results for areas of responsibility. Resourceful and persistent in overcoming obstacles, even when confronted with ambiguity or barriers. Takes pride in delivering high quality work.
- Applies extensive knowledge of regulatory requirements, industry drivers and practices to develop innovative approaches and manage the work of a team. Anticipates potential changes and challenges the status quo to drive continuous improvement.
- Develops and manages plans, establishes timelines, sets standards for performance and balances commitments to complete multiple activities and achieve results for areas of responsibility.
- Strong interpersonal skills and demonstrable ability to accommodate differing views to influence an agreed upon resolution. Identifies potential for conflict and takes preventive action.
- Effective builder of cohesive teams, facilitates team alignment and achievement of common goals. Independently engages internal and external stakeholders to establish productive collaborative relationships.
- Establishes objectives for areas of responsibility and plans for successful outcomes, consistent with Regulatory Affairs strategy.
- Demonstrates advanced skill and insight in gathering, analyzing and applying key information to solve complex problems. Provides regulatory expertise to cross-functional teams. Understands longer term consequences of decisions and actions.
- Effectively leads and manages a team, acting with integrity to build trust and execute on team objectives and departmental goals. Serves as a role model, encouraging others to behave ethically; takes accountability for self and group actions.
JOB COMPLEXITY:
- Capable of proactively assessing workload, trends, tasks and priorities for cross-functional activity.
- Plans and executes multiple projects or activities, considering alternative methods and contingency plans to avoid potential issues.
- Designs and implements solutions to address cross functional project level challenges, taking into consideration the broader impact.
- Engages, influences and collaborates with stakeholders on cross-functional projects.
WORKING CONDITIONS:
- Travel approximately 20%
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state, or local protected class.
Notice to Recruiters/Staffing Agencies
Recruiters and staffing agencies should not contact Exelixis, Inc. through this page. We require that all recruiters and staffing agencies have a signed contract on file and be assigned a specific search by our human resources department. Any resumes submitted through the website or directly by recruiters or staffing agencies that do not meet the above-mentioned criteria will be considered unsolicited and the company will not be responsible for any related fees.
Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $248,000 - $352,500 annually. The base pay range may take into account the candidate’s geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate’s geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
If you have a disability and need an accommodation in relation to the application and/or recruitment process, please email us at: recruiting@exelixis.com.
WORKING CONDITIONS:
Our office is a modern space that fosters collaboration and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.
DISCLAIMER:
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
SUMMARY/JOB PURPOSE:
Responsible for driving the development and implementation of global regulatory strategies that align with asset and corporate goals as well as health authority requirements. Ensures timely preparation of organized, consistent, and scientifically valid submissions. Provides expertise in translating regulatory requirements into practical, workable plans. Communicates clearly and proactively with stakeholders to reduce regulatory risk and drive the implementation of appropriate mitigation strategies.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Interact directly with regulatory authorities.
- Conduct effective and timely regulatory intelligence and research to provide guidance to study and asset teams. Provide risk assessments and recommendations for various regulatory scenarios, including possible expedited pathways.
- Represent Regulatory Affairs in multi-disciplinary teams to establish development and regulatory strategies for early and late-stage development programs.
- Work with external vendors to plan, review, prepare, submit, and maintain CTAs in Europe, Asia, and other regions.
- Review clinical trial-related documentation (e.g., protocols, informed consents, clinical study reports) for compliance with regulatory guidance and alignment with study objectives and regulatory strategy.
- Lead, author and evaluate documents submitted to regulatory health authorities to ensure they are complete, organized, of high quality, contain appropriate messaging and compliant with applicable regional regulations.
- Oversee the preparation and completion of regulatory submissions (electronic and paper), including investigational new drug applications, supplements and amendments, IND safety reports, annual reports/DSURs, other routine amendments, and new drug applications (NDA)/biologics license applications (BLA).
- Contribute to the implementation of processes and procedures, including developing and authoring internal work instructions and company SOPs.
- Lead multiple assets and/or studies as assigned.
SUPERVISORY RESPONSIBILITIES:
- Directly supervise employees.
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:
- Bachelor’s degree in related discipline and a minimum of fifteen years of related experience; or,
- Master’s degree in related discipline and a minimum of thirteen years of related experience; or,
- PhD degree in related discipline and a minimum of twelve years of related experience; or,
- Equivalent combination of education and experience.
Experience/The Ideal for Successful Entry into Job:
Knowledge/Skills:
- Develops and manages plans, establishes timelines, sets standards for performance. Manages and effectively communicates priorities. Motivates self and others to achieve business objectives and deliver results for areas of responsibility. Resourceful and persistent in overcoming obstacles, even when confronted with ambiguity or barriers. Takes pride in delivering high quality work.
- Applies extensive knowledge of regulatory requirements, industry drivers and practices to develop innovative approaches and manage the work of a team. Anticipates potential changes and challenges the status quo to drive continuous improvement.
- Develops and manages plans, establishes timelines, sets standards for performance and balances commitments to complete multiple activities and achieve results for areas of responsibility.
- Strong interpersonal skills and demonstrable ability to accommodate differing views to influence an agreed upon resolution. Identifies potential for conflict and takes preventive action.
- Effective builder of cohesive teams, facilitates team alignment and achievement of common goals. Independently engages internal and external stakeholders to establish productive collaborative relationships.
- Establishes objectives for areas of responsibility and plans for successful outcomes, consistent with Regulatory Affairs strategy.
- Demonstrates advanced skill and insight in gathering, analyzing and applying key information to solve complex problems. Provides regulatory expertise to cross-functional teams. Understands longer term consequences of decisions and actions.
- Effectively leads and manages a team, acting with integrity to build trust and execute on team objectives and departmental goals. Serves as a role model, encouraging others to behave ethically; takes accountability for self and group actions.
JOB COMPLEXITY:
- Capable of proactively assessing workload, trends, tasks and priorities for cross-functional activity.
- Plans and executes multiple projects or activities, considering alternative methods and contingency plans to avoid potential issues.
- Designs and implements solutions to address cross functional project level challenges, taking into consideration the broader impact.
- Engages, influences and collaborates with stakeholders on cross-functional projects.
WORKING CONDITIONS:
- Travel approximately 20%
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state, or local protected class.
Notice to Recruiters/Staffing Agencies
Recruiters and staffing agencies should not contact Exelixis, Inc. through this page. We require that all recruiters and staffing agencies have a signed contract on file and be assigned a specific search by our human resources department. Any resumes submitted through the website or directly by recruiters or staffing agencies that do not meet the above-mentioned criteria will be considered unsolicited and the company will not be responsible for any related fees.
Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $248,000 - $352,500 annually. The base pay range may take into account the candidate’s geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate’s geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
If you have a disability and need an accommodation in relation to the application and/or recruitment process, please email us at: recruiting@exelixis.com.
WORKING CONDITIONS:
Our office is a modern space that fosters collaboration and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.
DISCLAIMER:
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
See all Green Card Senior Director Regulatory Affairs Jobs
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Get Access To All JobsTips for Finding Green Card Sponsorship in Senior Director Regulatory Affairs
Verify your degree meets EB-2 requirements
An advanced degree in regulatory affairs, pharmacy, biochemistry, or a related life sciences field is the standard EB-2 baseline. A bachelor's plus five years of progressive regulatory experience can substitute if your employer documents the equivalency during PERM.
Target employers with active PERM filings
Use the OFLC Wage Search to confirm whether a prospective employer has recently filed PERM applications for regulatory affairs titles. Companies with existing PERM infrastructure move faster and understand the documentation burden for senior-level roles.
Search green card sponsoring jobs on Migrate Mate
Migrate Mate filters Senior Director Regulatory Affairs openings by green card sponsorship history, so you're applying to employers who have already navigated PERM for comparable roles rather than introducing the process to an unprepared HR team.
Align your FDA submission record with job requirements
PERM requires the employer to demonstrate no qualified U.S. worker is available. Your NDA, BLA, or 510(k) submission history, documented with dates and regulatory outcomes, strengthens the case that your credentials meet genuinely specialized requirements.
Negotiate green card sponsorship timing before accepting an offer
Ask during final-round negotiations whether the company will initiate PERM within your first year. Senior director offers with equity or sign-on bonuses are strong leverage points to formalize a sponsorship commitment before you sign.
Understand EB-2 versus EB-3 before PERM is filed
Your employer chooses the category when filing the I-140. EB-2 requires documenting an advanced degree or equivalent; EB-3 applies if the role is defined at the bachelor's level. The choice affects your priority date and wait time, so confirm it with your employer before DOL filing.
Green Card Senior Director Regulatory Affairs: Frequently Asked Questions
Does a Senior Director Regulatory Affairs role typically qualify for EB-2 or EB-3 sponsorship?
Most Senior Director Regulatory Affairs positions qualify for EB-2 because employers routinely require a master's degree or a bachelor's degree with substantial progressive experience in a regulatory discipline. If the employer defines the minimum requirement at the bachelor's level without an advanced degree requirement, EB-3 may apply instead. The PERM labor certification filing locks in the category, so confirm the degree requirement with your employer before the process begins.
How does green card sponsorship differ from H-1B for this role?
H-1B visa sponsorship is temporary, capped at 85,000 per fiscal year, and subject to a lottery for most applicants. EB-2 and EB-3 green card sponsorship through PERM is permanent residency, has no annual lottery, and results in an I-140 immigrant petition tied to your priority date rather than a temporary status. The PERM process itself takes longer to initiate, typically six months to two years from job offer to I-140 approval, but the outcome is a path to lawful permanent residency rather than a visa renewal cycle.
What does the PERM labor certification process look like for a senior regulatory role?
Your employer files the PERM application with DOL after completing a mandatory recruitment period, usually 30 to 60 days of documented U.S. candidate outreach. For a Senior Director Regulatory Affairs role, the job requirements posted during recruitment must match exactly what appears on the PERM application. DOL audits are more common for senior titles, so employers with in-house immigration counsel or prior PERM experience for regulatory roles handle this more efficiently.
How can I find Senior Director Regulatory Affairs jobs where the employer already sponsors green cards?
Migrate Mate lets you filter regulatory affairs roles specifically by green card sponsorship history, which means you're seeing employers who have already filed PERM applications for comparable titles. Applying to companies with an established sponsorship track record significantly reduces the risk that your offer falls through because the employer is unfamiliar with the PERM process or unwilling to commit to the timeline.
Can my employer start the PERM process while I'm on H-1B status?
Yes. Many foreign professionals in Senior Director Regulatory Affairs roles begin the PERM process while maintaining H-1B status. Filing PERM and an I-140 does not require you to change status, and once your I-140 is approved with a current priority date, you can file for adjustment of status to a green card through USCIS without leaving the U.S. Your H-1B can be extended beyond the standard six-year cap once your I-140 is approved and your priority date is within one year of becoming current.