E-3 Visa Regulatory Affairs Director Jobs
Regulatory Affairs Director roles in the U.S. qualify as E-3 specialty occupations, requiring a degree in life sciences, pharmacy, or a related regulatory field. Australian professionals can secure E-3 visa sponsorship without entering a lottery, and the visa renews indefinitely as long as you hold a qualifying position.
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Get Access To All JobsJob Description
The Senior Director, Oncology Cell and Gene Therapy Regulatory Affairs, leads the development and implementation of the global regulatory strategy for CGT products of high complexity and visibility and may serve as Franchise GRL on complex programs with multiple indications. In addition to GRL responsibilities, the Sr RAD has the ability to function in dual capacity by also serving as a regional lead based on their location.
The Sr RAD ensures that the regulatory strategy is designed to deliver efficient approval with competitive labelling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients. The Sr RAD provides team leadership and participates in coaching and mentorship to members of the relevant CGT Global Regulatory Strategy Team and is responsible for leading the global regulatory deliverables in line with GPT goals. The Sr RAD establishes external relationships with key Regulatory stakeholders, leveraging these to maintain competitive advantage. They are viewed as a Senior Leader within the Regulatory Community.
Typical Accountabilities
- Lead and own the development and implementation of the global regulatory strategy for a CGT product of high complexity, from current stage through BLA submission. May serve in dual-role as GRL and regional RAD.
- As a core member of the global product team, ensure that regulatory strategies are designed to deliver an efficient path to approval with competitive labeling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients, and contribute to governance presentations.
- Lead regulatory strategy for all health authority meetings, responses to information requests, BLA development and submission, expedited pathway designations.
- Maintain a strong working knowledge of the relevant disease areas: early- and late-stage multiple myeloma.
- Lead a Global Regulatory Strategy Team (GRST) responsible for specific indications/programs within the franchise, key contributing members from the regions, emerging markets, RA CMC, Labeling and members of the submission and execution team. Participate in coaching and performance feedback to members of your GRST.
- Lead the objective assessment of emerging data against aspirations and update senior management on project risks/mitigation activities.
- Represent Regulatory Affairs on Global Product Teams (GPTs) providing strategic Regulatory advice and accountable for all Regulatory activities.
- Accountable for the delivery of all project-related regulatory milestones, including assessment of the probability of regulatory success and mitigations. You will lead preparation of the regulatory strategy document and target product labeling.
- Demonstrate strategic, leadership, and collaboration skills, contributing to effective cross-functional teamwork in product development.
- Lead, participate, and promote non-project functional or cross-functional initiatives and engage externally on the corresponding topics as needed. Lead the development of novel regulatory tools and technology.
- Ensure appropriate planning and construction of the global dossier and core prescribing information led by the respective teams. Accountable for product maintenance and compliance activities associated with marketed brands.
- Partner with marketing companies (countries) and regional regulatory affairs staff to influence developing views/guidance.
- May have line management responsibilities in addition to matrixed supervisory, leadership, and mentoring roles.
Education, Qualifications, Skills and Experience
Essential
- An advanced degree in a science related field and seven-ten years of experience and/or appropriate knowledge/experience.
- Demonstrated success in cell and/or gene therapy regulatory strategy.
- Deep understanding of global regulatory science and integration with program strategy. Long standing experience of overall drug/biologic development processes and strategies for high profile, complex or novel development programs.
- Experience with product development for multiple myeloma.
- Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs. Experience in Oncology (small molecules & biologics) is preferred.
- Proven experience leading regulatory and cross-functional teams, and stakeholder management.
- Ability to think strategically and critically and evaluate risks to regulatory activities.
- Previous experience in leading major Health Authority interactions.
- Excellent oral, written, and presentation skills.
- Strong organizational skills.
- Ability to work in a fast-paced environment in a hands-on fashion.
- Flexible and proactive, with the ability to manage multiple projects and successfully adapt to changing business needs and priorities.
Desirable
- Successful leadership of at least one global regulatory approval including leading response team and labeling negotiations.
- Experience with FDA advisory committee and EMA oral explanation.
- Experience developing products for the treatment of autoimmune conditions.
- Experience working on due diligence activities and in a business alliance environment.
- Experience in leading and growing people through coaching or mentorship.
- Contribution to non-project business initiatives (e.g. at a portfolio or cross functional level).
At AstraZeneca, Regulatory professionals help turn breakthrough science into real solutions for patients with serious diseases by shaping innovative pathways through complex global requirements. Working with colleagues across locations, therapy areas and external partners, this role offers the chance to influence strategy end-to-end, from early development through rapid global approvals, while learning from leading experts, sharing best practices and using data, technology and modern approaches to reduce barriers for patients worldwide.
If this opportunity to drive transformative cell and gene therapies towards approval resonates, apply now to join us in bringing life-changing medicines to those who need them most.
Compensation
- Competitive salary and benefits package on offer:
Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week.
The annual base salary for this position ranges from $218,058.40 - 327,087.60. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Job Description
The Senior Director, Oncology Cell and Gene Therapy Regulatory Affairs, leads the development and implementation of the global regulatory strategy for CGT products of high complexity and visibility and may serve as Franchise GRL on complex programs with multiple indications. In addition to GRL responsibilities, the Sr RAD has the ability to function in dual capacity by also serving as a regional lead based on their location.
The Sr RAD ensures that the regulatory strategy is designed to deliver efficient approval with competitive labelling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients. The Sr RAD provides team leadership and participates in coaching and mentorship to members of the relevant CGT Global Regulatory Strategy Team and is responsible for leading the global regulatory deliverables in line with GPT goals. The Sr RAD establishes external relationships with key Regulatory stakeholders, leveraging these to maintain competitive advantage. They are viewed as a Senior Leader within the Regulatory Community.
Typical Accountabilities
- Lead and own the development and implementation of the global regulatory strategy for a CGT product of high complexity, from current stage through BLA submission. May serve in dual-role as GRL and regional RAD.
- As a core member of the global product team, ensure that regulatory strategies are designed to deliver an efficient path to approval with competitive labeling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients, and contribute to governance presentations.
- Lead regulatory strategy for all health authority meetings, responses to information requests, BLA development and submission, expedited pathway designations.
- Maintain a strong working knowledge of the relevant disease areas: early- and late-stage multiple myeloma.
- Lead a Global Regulatory Strategy Team (GRST) responsible for specific indications/programs within the franchise, key contributing members from the regions, emerging markets, RA CMC, Labeling and members of the submission and execution team. Participate in coaching and performance feedback to members of your GRST.
- Lead the objective assessment of emerging data against aspirations and update senior management on project risks/mitigation activities.
- Represent Regulatory Affairs on Global Product Teams (GPTs) providing strategic Regulatory advice and accountable for all Regulatory activities.
- Accountable for the delivery of all project-related regulatory milestones, including assessment of the probability of regulatory success and mitigations. You will lead preparation of the regulatory strategy document and target product labeling.
- Demonstrate strategic, leadership, and collaboration skills, contributing to effective cross-functional teamwork in product development.
- Lead, participate, and promote non-project functional or cross-functional initiatives and engage externally on the corresponding topics as needed. Lead the development of novel regulatory tools and technology.
- Ensure appropriate planning and construction of the global dossier and core prescribing information led by the respective teams. Accountable for product maintenance and compliance activities associated with marketed brands.
- Partner with marketing companies (countries) and regional regulatory affairs staff to influence developing views/guidance.
- May have line management responsibilities in addition to matrixed supervisory, leadership, and mentoring roles.
Education, Qualifications, Skills and Experience
Essential
- An advanced degree in a science related field and seven-ten years of experience and/or appropriate knowledge/experience.
- Demonstrated success in cell and/or gene therapy regulatory strategy.
- Deep understanding of global regulatory science and integration with program strategy. Long standing experience of overall drug/biologic development processes and strategies for high profile, complex or novel development programs.
- Experience with product development for multiple myeloma.
- Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs. Experience in Oncology (small molecules & biologics) is preferred.
- Proven experience leading regulatory and cross-functional teams, and stakeholder management.
- Ability to think strategically and critically and evaluate risks to regulatory activities.
- Previous experience in leading major Health Authority interactions.
- Excellent oral, written, and presentation skills.
- Strong organizational skills.
- Ability to work in a fast-paced environment in a hands-on fashion.
- Flexible and proactive, with the ability to manage multiple projects and successfully adapt to changing business needs and priorities.
Desirable
- Successful leadership of at least one global regulatory approval including leading response team and labeling negotiations.
- Experience with FDA advisory committee and EMA oral explanation.
- Experience developing products for the treatment of autoimmune conditions.
- Experience working on due diligence activities and in a business alliance environment.
- Experience in leading and growing people through coaching or mentorship.
- Contribution to non-project business initiatives (e.g. at a portfolio or cross functional level).
At AstraZeneca, Regulatory professionals help turn breakthrough science into real solutions for patients with serious diseases by shaping innovative pathways through complex global requirements. Working with colleagues across locations, therapy areas and external partners, this role offers the chance to influence strategy end-to-end, from early development through rapid global approvals, while learning from leading experts, sharing best practices and using data, technology and modern approaches to reduce barriers for patients worldwide.
If this opportunity to drive transformative cell and gene therapies towards approval resonates, apply now to join us in bringing life-changing medicines to those who need them most.
Compensation
- Competitive salary and benefits package on offer:
Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week.
The annual base salary for this position ranges from $218,058.40 - 327,087.60. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
See all 17+ Regulatory Affairs Director jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Regulatory Affairs Director roles.
Get Access To All JobsTips for Finding E-3 Visa Sponsorship as a Regulatory Affairs Director
Translate your TGA credentials for U.S. hiring managers
Frame your Therapeutic Goods Administration experience explicitly in FDA and ICH framework terms on your resume. U.S. employers assess regulatory fluency by the acronyms and dossier types you cite, and TGA-only language often gets filtered out before interviews.
Target employers with active FDA submission histories
Search DOL LCA disclosure data for companies that have filed Labor Condition Applications under regulatory affairs job titles. Employers already familiar with federal submission workflows are far more likely to understand and support the E-3 sponsorship process.
Search Migrate Mate to find sponsoring employers
Use Migrate Mate to filter Regulatory Affairs Director roles by employers who have sponsored E-3 or H-1B visas before. This removes the guesswork of cold-applying to companies that have never navigated visa sponsorship for this role type.
Clarify your specialty occupation case before applying
Regulatory Affairs Director roles generally qualify as specialty occupations, but your offer letter must describe duties requiring a specific degree field. Vague job descriptions linking any bachelor's to the role can create problems at the consulate, so request precise language from your employer before the LCA is filed.
Secure your LCA before negotiating your start date
DOL must certify your Labor Condition Application before you can attend your visa interview. LCA processing typically runs seven business days, but your employer's legal or HR team needs lead time. Build at least three weeks of buffer between your accepted offer and your proposed first day.
Use Migrate Mate's E-3 filing service for the full process
Once you have an offer, use Migrate Mate's E-3 filing service to handle your LCA submission, DS-160, and consulate preparation. Regulatory affairs cases often involve specialized degree-to-role matching that benefits from expert review before your interview documents are finalized.
Regulatory Affairs Director jobs are hiring across the US. Find yours.
Find Regulatory Affairs Director JobsRegulatory Affairs Director E-3 Visa: Frequently Asked Questions
How do I find Regulatory Affairs Director jobs with E-3 visa sponsorship?
Use Migrate Mate to search Regulatory Affairs Director roles filtered by employers with E-3 or H-1B sponsorship history. Generic job boards don't surface visa sponsorship willingness, so you end up cold-applying to companies that have never sponsored a work visa. Migrate Mate surfaces employers already familiar with the process, which significantly shortens your search timeline.
How much does it cost to get an E-3 visa?
Migrate Mate's E-3 filing service covers the entire process for $499, including the Labor Condition Application, visa document preparation, and consulate appointment guidance. Traditional immigration lawyers charge $2,000–$5,000+ for the same work. The E-3 has less paperwork than most work visas, so paying thousands for legal help is usually unnecessary.
Does a Regulatory Affairs Director role qualify as an E-3 specialty occupation?
Yes, in most cases. USCIS and consular officers assess whether the position normally requires at least a bachelor's degree in a specific field such as life sciences, pharmacy, chemistry, or regulatory science. The role's written duties must reflect that requirement. Generic language like 'bachelor's degree in a related field' can weaken the case, so work with your employer to ensure the offer letter and LCA describe the position with enough specificity.
How does the E-3 visa compare to the H-1B for Regulatory Affairs Director roles?
The E-3 has no lottery and no annual cap, so you can apply at any point in the year after receiving an offer. H-1B registrations open once a year and are subject to random selection, meaning qualified candidates are frequently excluded. For Australian nationals, the E-3 is almost always the faster and more predictable path to a U.S. Regulatory Affairs Director role.
Can I change employers or move between regulatory roles while on an E-3?
Yes, but each employer change requires a new LCA and, if you're outside the U.S., a new visa stamp. If you're already in the U.S. in valid E-3 status, you can start with a new employer once the new LCA is certified, without waiting for a new visa stamp if your current stamp is still valid. Promotions within the same company that substantially change your job duties may also require a new LCA.
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