TN Visa Regulatory Affairs Director Jobs
Regulatory Affairs Director roles qualify for TN visa sponsorship under the USMCA's Scientific category, covering professionals who oversee regulatory submissions, compliance programs, and agency relations with bodies like the FDA. Canadian citizens can apply at the border or consulate with no cap; Mexican citizens require consular processing.
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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 69+ 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 TN Visa Sponsorship as a Regulatory Affairs Director
Match your credentials to Scientific category requirements
TN eligibility for Regulatory Affairs Directors falls under the Scientific category, which requires a relevant degree in life sciences, chemistry, or a related field. Gather your transcripts and degree certificate before applying, since CBP officers verify field-of-study alignment on the spot.
Target employers with FDA submission track records
Prioritize pharma, biotech, and medical device companies that file regularly with the FDA, since their legal and HR teams already understand TN documentation. A role managing INDs, NDAs, or 510(k)s signals the job is substantive enough to survive CBP scrutiny on specialty-occupation grounds.
Get the offer letter language right before filing
Your offer letter must describe the role using language that maps clearly to the USMCA Scientific category. Vague titles like 'Regulatory Consultant' create unnecessary CBP risk. Ask the employer to specify degree requirements and regulatory functions in the letter before you travel to the port of entry.
Use Migrate Mate to find verified sponsorship-ready employers
Search Migrate Mate to identify Regulatory Affairs Director roles at employers actively offering TN visa sponsorship. This avoids wasting time on applications where sponsorship support is uncertain and gets you directly to roles structured for USMCA-category professionals.
Prepare a regulatory portfolio for CBP or consular review
Unlike a resume, a portfolio showing agency correspondence, submission timelines, or cross-functional sign-off processes demonstrates the seniority and specialization CBP expects at the Director level. Mexican nationals applying at a consulate should bring this documentation to the interview.
Align your TN status duration with the regulatory project cycle
TN status is granted in up to three-year increments with no cap on renewals. If you're joining a company mid-submission cycle, ask your employer to request the full three years so your authorization covers product approval timelines without requiring early renewal paperwork.
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Find Regulatory Affairs Director JobsRegulatory Affairs Director TN Visa: Frequently Asked Questions
Does a Regulatory Affairs Director role qualify for TN visa sponsorship?
Yes. Regulatory Affairs Directors typically qualify under the USMCA's Scientific category, which covers professionals applying scientific expertise to regulatory compliance and agency submissions. Your degree must be in a relevant field such as chemistry, biology, pharmacy, or a related life science. CBP will assess both your credentials and whether the role's actual duties match the category description.
How does TN visa sponsorship compare to H-1B for this role?
TN visa sponsorship is significantly more straightforward for Regulatory Affairs Directors than H-1B. There is no annual lottery, no USCIS petition required for Canadian citizens, and no multi-month wait for approval. Canadians can receive TN status at the port of entry the same day. H-1B requires employer sponsorship through a lottery and an October 1 start date, adding 6 to 18 months of uncertainty before you can begin work.
What documentation does my employer need to provide for my TN application?
Your employer must provide a support letter on company letterhead that specifies your job title, a description of duties tied to the USMCA Scientific category, your required credentials, the duration of employment, and confirmation that you will be paid. For Regulatory Affairs Directors, the letter should reference regulatory functions such as FDA submissions, compliance oversight, or agency liaison work to clearly establish the professional nature of the role.
Where can I find Regulatory Affairs Director jobs that offer TN visa sponsorship?
Migrate Mate is built specifically for Canadian and Mexican professionals searching for roles with TN visa sponsorship. Rather than filtering through generic job postings where sponsorship availability is unclear, Migrate Mate surfaces employers that are already set up to support TN applicants, so you can focus your search on positions where your visa status won't be an obstacle.
Can Mexican nationals apply for TN visa sponsorship for this role the same way Canadians can?
No. Mexican nationals must apply for TN status at a U.S. consulate in Mexico and receive a TN visa stamp before traveling to the United States, unlike Canadian citizens who can seek admission directly at a port of entry. The consular process requires scheduling an interview and typically takes several weeks. The substantive requirements, including the employer letter and credential documentation, are the same for both nationalities.
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