Senior Director Regulatory Affairs Jobs
Senior Director Regulatory Affairs jobs are open across pharmaceuticals, medical devices, biotechnology, and consumer health, from senior director to VP and C-suite-adjacent levels, with specializations in drug development, combination products, and global regulatory strategy. Find a role that fits from the openings below and apply directly.
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X-energy LLC conducts a thorough recruiting process and will never issue offers without interview to discuss qualifications and responsibilities. All applications will be submitted via our company career page, www.x-energy.com/careers/ . We will never ask you to provide payment information as part of the recruiting process. If anyone claiming to represent X-energy directs you in a manner otherwise, please contact us at www.x-energy.com/contact-us .
Job Description
Join X-energy’s growing regulatory affairs team to jumpstart new reactor projects and develop licensing approaches for first-of-a-kind deployment strategies. Licensing Engineers at X-energy lead new application preparation, drive licensing strategy, and coordinate the business, licensing, and technical activities necessary to further the deployment of X-energy reactors globally.Licensing Engineers are engaged in environmental licensing, nuclear safety, nuclear security, emergency planning, safeguards, and regulatory compliance for X-energy's advanced high-temperature gas-cooled reactor technology. This position offers the opportunity to contribute to first-of-a-kind advanced reactor projects that define industry-best licensing practices.
Job Profile Tasks/Responsibilities
Licensing Engineers in Regulatory Affairs are responsible for activities including, but not limited to, the following:
- Supporting licensing activities associated with reactor certifications, permits, and licenses, including the preparation of regulatory engagement plans, applications, white papers, technical reports, and topical reports
- Ensuring compliance with NRC regulations and guidance
- Participating in and presenting at public meetings, regulatory audits, and business proposals
- Researching and developing strategic proposals to address novel safety, environmental, and licensing challenges
- Analyzing policy, legislation, and regulations
- Developing guidance, processes, and templates to improve and implement licensing strategies for environmental and safety issues
- Working as part of a team to deliver timely and high-quality licensing products
- Effectively communicate complex technical and regulatory positions
- Supporting planning and executing the X-energy business and licensing strategy Participating in nuclear industry working groups
Job Profile Minimum Qualifications
- All Levels :
- Bachelor’s degree in engineering (e.g., mechanical, nuclear, chemical, or electrical engineering), science (e.g., environmental science, physics, or chemistry), or other related area.
- Preparing technical written and oral communications
- Understanding of nuclear reactor design and operation
- Project management experience, including developing and maintaining schedules; meeting deadlines; formulating budgets; working collaboratively; and leading teams
- Level I : Typically, up to two years of relevant technical or licensing experience
- Level II : Typically, three years of relevant technical or licensing experience
- Level III : Typically, five years of relevant technical or licensing experience
- Level IV : Typically, ten years of relevant technical or licensing experience
- Level V : Typically, fifteen years of relevant technical or licensing experience
- Level VI : Typically, twenty years of relevant technical or licensing experience
Preferred Skills
Candidates for this role would ideally have knowledge or experience in one or more of the following areas, commensurate with their educational and professional background:
- Knowledge of high-temperature gas reactor technologies and/or first-of-a-kind nuclear technologies
- Knowledge of U.S. NRC and/or U.S. DOE regulatory requirements for reactor licensing
- Experience with U.S. NRC construction permit and operating license application preparation and/or reviews
- Understanding of Environmental science(s) for nuclear reactor siting
- Knowledge of small modular reactor technical and licensing considerations
- Knowledge of international nuclear reactor licensing frameworks
- Experience with front-end loading project planning
- Ability to analyze and interpret regulatory requirements, legislation, and policy documents
Compensation
As required by Maryland and other applicable state law, X Energy, LLC (X-energy) lists the expected compensation range for a publicly advertised job opportunity based upon the job requirements (e.g. education/training, experience, skill sets, etc.). Individual candidates who meet the job requirements for the posted position will be offered a salary within this range based on their respective levels of education/training, experience, and other qualifications unique to them. Salary ranges may vary based on the specific office location and region referenced in the posting to take into consideration differences in cost of living and may not be reflective of all regions. Please note that compensation ranges listed for US job postings reflect base salary only and do not include benefits or other incentives.
Offers within the posted salary range are commensurate with the individual’s qualifications for the position, along with a view on internal equity, market data, and room for growth. The salary range for this position is:
Level I: $81,314 - $135,524 / Level II: $88,725 - $147,875 / Level III: $103,575 - $172,625 / Level IV: $143,550 - $183,425 / Level V: $165,000 - $190,000 / Level VI: $190,000 - $215,000Position Job Classification
Full time - ExemptBenefits
X Energy, LLC offers a robust benefits package that includes a 401K plan with an employer match, Medical/Dental /Vision Insurance, Life and Disability Insurance, Paid Time Off, and a Tuition Reimbursement/Professional Development policy that supports the continuing education of our employees.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
X Energy, LLC participates in E-Verify. Please visit the links below for more information about E-Verify and the protection of your Right to Work.
Right To Work Link: If you have the right to work, don't let anyone take it away (e-verify.gov)
E-Verify Participation Link: E-Verify Participation Poster English and Spanish
X-energy LLC conducts a thorough recruiting process and will never issue offers without interview to discuss qualifications and responsibilities. All applications will be submitted via our company career page, www.x-energy.com/careers/ . We will never ask you to provide payment information as part of the recruiting process. If anyone claiming to represent X-energy directs you in a manner otherwise, please contact us at www.x-energy.com/contact-us .
Job Description
Join X-energy’s growing regulatory affairs team to jumpstart new reactor projects and develop licensing approaches for first-of-a-kind deployment strategies. Licensing Engineers at X-energy lead new application preparation, drive licensing strategy, and coordinate the business, licensing, and technical activities necessary to further the deployment of X-energy reactors globally.Licensing Engineers are engaged in environmental licensing, nuclear safety, nuclear security, emergency planning, safeguards, and regulatory compliance for X-energy's advanced high-temperature gas-cooled reactor technology. This position offers the opportunity to contribute to first-of-a-kind advanced reactor projects that define industry-best licensing practices.
Job Profile Tasks/Responsibilities
Licensing Engineers in Regulatory Affairs are responsible for activities including, but not limited to, the following:
- Supporting licensing activities associated with reactor certifications, permits, and licenses, including the preparation of regulatory engagement plans, applications, white papers, technical reports, and topical reports
- Ensuring compliance with NRC regulations and guidance
- Participating in and presenting at public meetings, regulatory audits, and business proposals
- Researching and developing strategic proposals to address novel safety, environmental, and licensing challenges
- Analyzing policy, legislation, and regulations
- Developing guidance, processes, and templates to improve and implement licensing strategies for environmental and safety issues
- Working as part of a team to deliver timely and high-quality licensing products
- Effectively communicate complex technical and regulatory positions
- Supporting planning and executing the X-energy business and licensing strategy Participating in nuclear industry working groups
Job Profile Minimum Qualifications
- All Levels :
- Bachelor’s degree in engineering (e.g., mechanical, nuclear, chemical, or electrical engineering), science (e.g., environmental science, physics, or chemistry), or other related area.
- Preparing technical written and oral communications
- Understanding of nuclear reactor design and operation
- Project management experience, including developing and maintaining schedules; meeting deadlines; formulating budgets; working collaboratively; and leading teams
- Level I : Typically, up to two years of relevant technical or licensing experience
- Level II : Typically, three years of relevant technical or licensing experience
- Level III : Typically, five years of relevant technical or licensing experience
- Level IV : Typically, ten years of relevant technical or licensing experience
- Level V : Typically, fifteen years of relevant technical or licensing experience
- Level VI : Typically, twenty years of relevant technical or licensing experience
Preferred Skills
Candidates for this role would ideally have knowledge or experience in one or more of the following areas, commensurate with their educational and professional background:
- Knowledge of high-temperature gas reactor technologies and/or first-of-a-kind nuclear technologies
- Knowledge of U.S. NRC and/or U.S. DOE regulatory requirements for reactor licensing
- Experience with U.S. NRC construction permit and operating license application preparation and/or reviews
- Understanding of Environmental science(s) for nuclear reactor siting
- Knowledge of small modular reactor technical and licensing considerations
- Knowledge of international nuclear reactor licensing frameworks
- Experience with front-end loading project planning
- Ability to analyze and interpret regulatory requirements, legislation, and policy documents
Compensation
As required by Maryland and other applicable state law, X Energy, LLC (X-energy) lists the expected compensation range for a publicly advertised job opportunity based upon the job requirements (e.g. education/training, experience, skill sets, etc.). Individual candidates who meet the job requirements for the posted position will be offered a salary within this range based on their respective levels of education/training, experience, and other qualifications unique to them. Salary ranges may vary based on the specific office location and region referenced in the posting to take into consideration differences in cost of living and may not be reflective of all regions. Please note that compensation ranges listed for US job postings reflect base salary only and do not include benefits or other incentives.
Offers within the posted salary range are commensurate with the individual’s qualifications for the position, along with a view on internal equity, market data, and room for growth. The salary range for this position is:
Level I: $81,314 - $135,524 / Level II: $88,725 - $147,875 / Level III: $103,575 - $172,625 / Level IV: $143,550 - $183,425 / Level V: $165,000 - $190,000 / Level VI: $190,000 - $215,000Position Job Classification
Full time - ExemptBenefits
X Energy, LLC offers a robust benefits package that includes a 401K plan with an employer match, Medical/Dental /Vision Insurance, Life and Disability Insurance, Paid Time Off, and a Tuition Reimbursement/Professional Development policy that supports the continuing education of our employees.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
X Energy, LLC participates in E-Verify. Please visit the links below for more information about E-Verify and the protection of your Right to Work.
Right To Work Link: If you have the right to work, don't let anyone take it away (e-verify.gov)
E-Verify Participation Link: E-Verify Participation Poster English and Spanish
Senior Director Regulatory Affairs Jobs by Experience Level
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Find JobsSenior Director Regulatory Affairs Job Market
Who's Hiring
- Katalyst Healthcares & Life Sciences48
- Revolution Medicines18
- AbbVie17
- BD14
- Abbott11
Top Industries Hiring
- Biotechnology & Pharmaceuticals59
- Medical Devices11
- Healthcare & Medical Services11
- Consulting & Professional Services9
- Science & Research5
What Employers Look For
The qualifications that appear most often in senior director regulatory affairs jobs.
- Bachelor's or advanced degree in life sciences, pharmacy, chemistry, or a related field
- 10 or more years of regulatory affairs experience in pharmaceutical, biotech, or medical device sectors
- Direct experience leading FDA submissions such as NDAs, BLAs, 510(k)s, or PMAs
- Demonstrated ability to manage cross-functional teams and lead regulatory strategy across product lifecycles
- Familiarity with ICH guidelines, 21 CFR regulations, and international regulatory frameworks
- Regulatory Affairs Certification (RAC) from RAPS preferred or required by many employers
Tips for Your Senior Director Regulatory Affairs Job Search
Tailor your resume to submission types
Hiring managers want to see which submission types you've owned, whether NDAs, BLAs, 510(k)s, or PMAs. List the specific pathway, the product type, and whether you led the strategy or the execution. Generic regulatory experience won't differentiate you at the director level.
Apply early to roles that fit
Migrate Mate lists senior director regulatory affairs openings from across the United States in one place, so you can find roles that match and apply directly to each listing.
Quantify your regulatory approval outcomes
Approvals, timelines compressed, and submissions completed are the metrics that resonate with hiring committees. If you've reduced a submission cycle from 18 months to 12, say so. Directors who can translate regulatory work into business outcomes stand out against candidates who list only responsibilities.
Target openings by agency interaction level
Some roles are primarily internal, while others require frequent FDA meetings, Type B interactions, or agency correspondence. Identify which type fits your background and filter accordingly when you search, so your cover letter speaks directly to the scope the employer actually needs.
Prepare a 90-day regulatory plan for interviews
Senior director interviews often include a strategic scenario: how would you assess the regulatory posture here and what would you prioritize? Preparing a brief, structured framework, covering pipeline review, SOP gaps, and agency relationship audit, gives you a concrete answer ready to go.
Negotiate scope before you negotiate title
At this level, reporting structure and budget authority matter as much as compensation. Before your final interview round, clarify whether the role owns the regulatory strategy or executes someone else's, and whether you'd have direct FDA communication authority. Misalignment on scope is a common reason senior hires leave within the first year.
Senior Director Regulatory Affairs Jobs: Frequently Asked Questions
Which companies are hiring the most senior director regulatory affairss?
The companies hiring the most senior director regulatory affairss right now include Katalyst Healthcares & Life Sciences, Revolution Medicines, and AbbVie, with the largest share of openings in California, Massachusetts, and New Jersey, based on current listings on Migrate Mate as of November 2026. Pharmaceutical manufacturers and medical device companies consistently account for the majority of postings at this level.
How many senior director regulatory affairs jobs are remote?
About 72% of senior director regulatory affairs openings are fully remote or hybrid as of November 2026, reflecting the document-intensive and meeting-heavy nature of the role. Positions focused on regulatory strategy, submissions management, and policy tend to offer the most remote flexibility, while roles requiring frequent lab or manufacturing site presence are more commonly on-site.
How do you become a senior director regulatory affairs?
Most senior directors start with a life sciences degree, then build hands-on experience in regulatory roles at the associate or manager level before advancing to director. Earning a Regulatory Affairs Certification from RAPS strengthens your candidacy. Leading at least one major submission from strategy through approval, and developing experience managing a regulatory team, are the milestones that typically precede promotion to senior director.
Can you get hired as a senior director regulatory affairs without direct leadership experience?
It's uncommon to be hired as a senior director without prior people management experience, but some companies will promote strong individual contributors who have led cross-functional submission teams or served as regulatory lead on a complex program. If you're missing formal direct reports, emphasize project leadership, mentorship of junior staff, and any instances where you set regulatory strategy across an organization. Smaller companies and startups are more open to candidates building toward the full leadership profile.
What does the senior director regulatory affairs interview process look like?
The process typically involves an initial screen with a recruiter or HR partner, followed by a technical interview with the VP of Regulatory or Chief Regulatory Officer focused on submission experience and agency interaction history. A panel round with cross-functional peers from clinical, legal, and commercial is common. Final rounds often include a strategic presentation or case study where you walk through how you'd approach the regulatory posture for a pipeline asset or product issue.
Where can I find and apply to senior director regulatory affairs jobs?
You can find and apply to senior director regulatory affairs jobs on Migrate Mate, which lists current openings from employers across the United States. Search for roles that match your submission expertise, therapeutic area, and preferred work arrangement, then apply directly to each listing that fits.
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