Associate Director of Regulatory Affairs Visa Sponsorship Jobs in California
Associate director of regulatory affairs visa sponsorship jobs in California are concentrated in the San Francisco Bay Area, San Diego, and Los Angeles, where major pharmaceutical and biotech employers including Genentech, Gilead Sciences, Amgen, and AstraZeneca regularly file for specialty occupation visas. California's dense biotech corridor makes it one of the most active states for regulatory affairs sponsorship.
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Get Access To All JobsINTRODUCTION
Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.
JOB SUMMARY
In this role, you will be a core member of the Regulatory team and will be responsible for helping build and execute on global regulatory strategy, objectives, policies and programs pertaining to development and future marketing of products.
Responsibilities
- Provides regulatory strategic direction and support for assigned global development programs/development program activities
- Assists Sr. Regulatory Affairs staff with their development program activities and deliverables
- Designs and implements regulatory strategies with Regulatory Affairs staff to obtain and maintain product investigative and marketing applications for assigned programs, as well as their life cycle management
- Acts as regulatory representative on early and/or late phase clinical studies, ensuring compliant execution of trials
- Strong competency in understanding regulatory requirements and emerging regulatory landscapes associated with US and global regulatory authorities
- Experienced in responding to inquiries from global regulatory authorities as well as the preparation and conduct of meetings with global regulatory authorities
- Assist in the preparation and maintenance of Annual Reports, Development Safety Update Reports (DSURs), Investigator’s Brochures and other documents required for INDs, CTAs, NDAs and other related regulatory development and marketing applications
- Assist in the cataloging and maintenance of regulatory application submissions
- Conduct research and stay up-to-date on regulatory requirements and changes
- Collaborate with cross-functional teams to ensure product compliance throughout the development lifecycle
- Monitor and assess regulatory risks and develop mitigation strategies
- Oversee quality assurance processes to ensure compliance with regulatory standards
- Review SOPs pertaining to Regulatory
- Works strategically with all regulatory functions to develop detailed, actionable submission plans, tracks major submission deliverables, and ensures consistent management submission documents, health authority communications, and all other regulatory information supporting Nurix’s investigational and marketing applications
- Plays an essential part in defining requirements for, implementing, and supporting future systems and tools to be employed by Nurix in the areas of document management, submission content planning, and regulatory information management
- Tracks the status of major deliverables for regulatory submissions (e.g., study reports, summary documents, labeling) along with their dependencies
- Develops and maintains submission plan templates to ensure Nurix regulatory submissions are consistently planned and executed across programs
- Participates in cross-functional process initiatives impacting regulatory submission processes and systems
- Manages consultants and contractors as needed
EXPERIENCE AND SKILLS
- Bachelor's degree in life-sciences or related scientific discipline; advanced degree preferred
- Must have minimum of 8 years in Regulatory affairs strategy
- Strong demonstration of knowledge of drug development, FDA, EMA and ICH guidelines and regulations
- Experience providing hands-on support for planning clinical trial and marketing applications to health authorities including but not limited to FDA, EMA
- Ability to read, analyze and interpret scientific and technical information, as well as regulatory
- Ability to understand and explain detailed regulatory affairs and compliance programs and/or to effectively present information to senior regulatory management, other departments or external
- Ability to comply with changing regulatory
- Proven track record of supporting Regulatory affairs in the planning and execution of major filings and ongoing maintenance of clinical trial and marketing applications
- Strong project management and critical thinking skills
- Experience applying project management techniques and tools (e.g., MS Project, Smartsheet, Excel trackers) to the planning and execution of regulatory submissions
- Excellent organizational and communication skills, both written and verbal
- Ability to work independently as well as part of a team environment
- Positive attitude, energetic and proactive
- Proven ability to manage multiple projects, identify and resolve regulatory issues
- Strong interpersonal skills and the ability to effectively work with others
FIT WITH NURIX CULTURE AND VALUES
- Strong team orientation; highly collaborative
- Solutions and results-oriented focus
- Hands-on approach; resourceful and open to diverse points of view
SALARY RANGE
- SM $187,800 - $208,638
- AD $199,500 - $231,200
LOCATION
Brisbane, CA - Onsite
INTRODUCTION
Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.
JOB SUMMARY
In this role, you will be a core member of the Regulatory team and will be responsible for helping build and execute on global regulatory strategy, objectives, policies and programs pertaining to development and future marketing of products.
Responsibilities
- Provides regulatory strategic direction and support for assigned global development programs/development program activities
- Assists Sr. Regulatory Affairs staff with their development program activities and deliverables
- Designs and implements regulatory strategies with Regulatory Affairs staff to obtain and maintain product investigative and marketing applications for assigned programs, as well as their life cycle management
- Acts as regulatory representative on early and/or late phase clinical studies, ensuring compliant execution of trials
- Strong competency in understanding regulatory requirements and emerging regulatory landscapes associated with US and global regulatory authorities
- Experienced in responding to inquiries from global regulatory authorities as well as the preparation and conduct of meetings with global regulatory authorities
- Assist in the preparation and maintenance of Annual Reports, Development Safety Update Reports (DSURs), Investigator’s Brochures and other documents required for INDs, CTAs, NDAs and other related regulatory development and marketing applications
- Assist in the cataloging and maintenance of regulatory application submissions
- Conduct research and stay up-to-date on regulatory requirements and changes
- Collaborate with cross-functional teams to ensure product compliance throughout the development lifecycle
- Monitor and assess regulatory risks and develop mitigation strategies
- Oversee quality assurance processes to ensure compliance with regulatory standards
- Review SOPs pertaining to Regulatory
- Works strategically with all regulatory functions to develop detailed, actionable submission plans, tracks major submission deliverables, and ensures consistent management submission documents, health authority communications, and all other regulatory information supporting Nurix’s investigational and marketing applications
- Plays an essential part in defining requirements for, implementing, and supporting future systems and tools to be employed by Nurix in the areas of document management, submission content planning, and regulatory information management
- Tracks the status of major deliverables for regulatory submissions (e.g., study reports, summary documents, labeling) along with their dependencies
- Develops and maintains submission plan templates to ensure Nurix regulatory submissions are consistently planned and executed across programs
- Participates in cross-functional process initiatives impacting regulatory submission processes and systems
- Manages consultants and contractors as needed
EXPERIENCE AND SKILLS
- Bachelor's degree in life-sciences or related scientific discipline; advanced degree preferred
- Must have minimum of 8 years in Regulatory affairs strategy
- Strong demonstration of knowledge of drug development, FDA, EMA and ICH guidelines and regulations
- Experience providing hands-on support for planning clinical trial and marketing applications to health authorities including but not limited to FDA, EMA
- Ability to read, analyze and interpret scientific and technical information, as well as regulatory
- Ability to understand and explain detailed regulatory affairs and compliance programs and/or to effectively present information to senior regulatory management, other departments or external
- Ability to comply with changing regulatory
- Proven track record of supporting Regulatory affairs in the planning and execution of major filings and ongoing maintenance of clinical trial and marketing applications
- Strong project management and critical thinking skills
- Experience applying project management techniques and tools (e.g., MS Project, Smartsheet, Excel trackers) to the planning and execution of regulatory submissions
- Excellent organizational and communication skills, both written and verbal
- Ability to work independently as well as part of a team environment
- Positive attitude, energetic and proactive
- Proven ability to manage multiple projects, identify and resolve regulatory issues
- Strong interpersonal skills and the ability to effectively work with others
FIT WITH NURIX CULTURE AND VALUES
- Strong team orientation; highly collaborative
- Solutions and results-oriented focus
- Hands-on approach; resourceful and open to diverse points of view
SALARY RANGE
- SM $187,800 - $208,638
- AD $199,500 - $231,200
LOCATION
Brisbane, CA - Onsite
Associate Director of Regulatory Affairs Job Roles in California
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Search Associate Director of Regulatory Affairs Jobs in CaliforniaAssociate Director of Regulatory Affairs Jobs in California: Frequently Asked Questions
Which companies sponsor visas for associate directors of regulatory affairs in California?
California's pharmaceutical and biotech sector produces consistent sponsorship activity for regulatory affairs roles. Employers with documented H-1B visa filing history for regulatory positions include Genentech, Gilead Sciences, Amgen, Pfizer, AstraZeneca, Regeneron, and Alexion. Medical device companies such as Abbott and Boston Scientific also sponsor in this state. Sponsorship patterns vary by company size, pipeline activity, and submission workload in a given year.
Which visa types realistically fit associate director of regulatory affairs roles in California?
The H-1B is the most common pathway, as regulatory affairs director roles require a bachelor's degree in a directly related field such as pharmacy, chemistry, biology, or a life science, satisfying the specialty occupation requirement. The employer files an LCA with DOL and an I-129 petition with USCIS. Australian nationals may qualify under the E-3 visa, and Chilean or Singaporean nationals may qualify under the H-1B1 visa. An EB-2 or EB-3 employment-based green card is the typical long-term pathway, usually requiring PERM labor certification. F-1 students may use OPT to work in the role while pursuing permanent sponsorship.
Which cities in California have the most associate director of regulatory affairs sponsorship jobs?
San Diego leads in volume, anchored by a concentration of biotech and pharmaceutical companies including Daiichi Sankyo, Neurocrine Biosciences, and Halozyme. The San Francisco Bay Area, particularly South San Francisco and Foster City, is home to Genentech and Gilead Sciences, generating consistent regulatory affairs hiring. Los Angeles and the surrounding area has a smaller but active market, primarily through specialty pharmaceutical and medical device companies.
How to find associate director of regulatory affairs visa sponsorship jobs in California?
Migrate Mate lists associate director of regulatory affairs roles in California from employers with verified visa sponsorship history, so you can focus on companies that have demonstrated willingness to sponsor rather than applying broadly. Filtering by California narrows results to the Bay Area, San Diego, and Los Angeles markets where regulatory affairs hiring is most active. Reviewing employer filing history on Migrate Mate helps identify which companies have sponsored comparable senior regulatory roles before.
Are there any California-specific factors that affect visa sponsorship for regulatory affairs roles?
California's biotech and pharmaceutical industry is among the largest in the country, which creates a relatively high baseline of H-1B and employment-based green card filings for regulatory affairs positions. The state's proximity to FDA district offices in San Francisco and Los Angeles can influence employer hiring urgency around IND, NDA, and BLA submission cycles. Regulatory affairs roles tied to late-stage pipeline programs tend to generate faster and more committed sponsorship timelines, as the positions are closely linked to product approval outcomes.
What is the prevailing wage for sponsored associate director of regulatory affairs jobs in California?
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.